Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies (NCT NCT03130959)

NCT ID: NCT03130959

Last Updated: 2022-08-09

Results Overview

A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed \> 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 166 participants
• Primary outcome timeframe: up to 6 weeks post-dosing
• Results posted on: 2022-08-09

Participant Flow

166 participants were treated

Participant milestones

Measure	Arm A1 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm B1 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm A2 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm B2 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm A3 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Overall Study STARTED	23	22	16	15	15	15	12	10	19	19
Overall Study COMPLETED	0	12	0	1	0	9	0	6	0	4
Overall Study NOT COMPLETED	23	10	16	14	15	6	12	4	19	15

Reasons for withdrawal

Measure	Arm A1 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm B1 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm A2 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm B2 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm A3 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Overall Study Disease progression	19	7	12	7	12	3	6	3	15	8
Overall Study Study drug toxicity	2	2	1	2	1	1	3	0	3	3
Overall Study Other reasons	0	0	0	0	0	1	1	0	0	0
Overall Study Subject request to discontinue therapy	0	0	1	1	0	0	1	1	0	0
Overall Study Not reported	0	0	0	1	0	1	0	0	0	1
Overall Study Adverse Event unrelated to drug	0	0	1	1	1	0	1	0	1	1
Overall Study Participant withdrew consent	0	1	0	2	1	0	0	0	0	2
Overall Study Administrative reason by sponsor	1	0	1	0	0	0	0	0	0	0
Overall Study Lost to Follow-up	1	0	0	0	0	0	0	0	0	0

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies

Baseline characteristics by cohort

Measure	Arm A1 n=23 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm B1 n=22 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm A2 n=16 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm B2 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm A3 n=15 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=19 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Total n=166 Participants Total of all reporting groups
Age, Customized < 2 years old	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants
Age, Customized >= 2 and < 12 years old	15 Participants n=5 Participants	16 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	8 Participants n=115 Participants	4 Participants n=24 Participants	13 Participants n=42 Participants	12 Participants n=42 Participants	87 Participants n=42 Participants
Age, Customized >= 12 and < 18 years old	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	11 Participants n=21 Participants	9 Participants n=10 Participants	3 Participants n=115 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	6 Participants n=42 Participants	61 Participants n=42 Participants
Age, Customized >= 18 years old	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	15 Participants n=42 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	16 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	6 Participants n=115 Participants	3 Participants n=24 Participants	4 Participants n=42 Participants	10 Participants n=42 Participants	70 Participants n=42 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=10 Participants	6 Participants n=115 Participants	7 Participants n=24 Participants	15 Participants n=42 Participants	9 Participants n=42 Participants	96 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	14 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=10 Participants	5 Participants n=115 Participants	5 Participants n=24 Participants	8 Participants n=42 Participants	6 Participants n=42 Participants	60 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	10 Participants n=10 Participants	6 Participants n=115 Participants	4 Participants n=24 Participants	9 Participants n=42 Participants	13 Participants n=42 Participants	92 Participants n=42 Participants
Race/Ethnicity, Customized White	19 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants	14 Participants n=21 Participants	14 Participants n=10 Participants	7 Participants n=115 Participants	9 Participants n=24 Participants	18 Participants n=42 Participants	13 Participants n=42 Participants	132 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	9 Participants n=42 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	10 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants	14 Participants n=42 Participants

PRIMARY outcome

Timeframe: up to 6 weeks post-dosing

Population: Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants.

A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed > 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).

Outcome measures

Measure	Arm A1, Safety Lead-in n=15 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=10 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)	0 Number of participants	0 Number of participants	0 Number of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to 6 weeks post-dosing

Population: Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants.

The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study.

Outcome measures

Measure	Arm A1, Safety Lead-in n=15 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=10 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)	7 Number of participants	6 Number of participants	8 Number of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From first dose to 30 days post-last dose (up to approximately 6 weeks)

Population: Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants.

The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy.

Outcome measures

Measure	Arm A1, Safety Lead-in n=15 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=10 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation	3 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to approximately 42 months

Population: All treated participants

Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1.

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in Module B, Cohorts 2 through 5	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Overall Survival (OS), Cohort 1 Only	11.66 months Interval 10.32 to 16.46	10.78 months Interval 9.13 to 15.77	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: up to approximately 42 months

Population: All treated participants

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.

Outcome measures

Measure	Arm A1, Safety Lead-in n=16 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=15 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=15 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Progression-Free Survival (PFS), Cohorts 2-4	1.74 months Interval 1.35 to 2.73	1.31 months Interval 1.18 to 1.45	1.38 months Interval 1.22 to 1.38	2.76 months Interval 1.48 to 4.53	1.41 months Interval 1.41 to 2.6	4.60 months Interval 1.41 to 5.39	—	—	—	—

PRIMARY outcome

Timeframe: up to approximately 42 months

Population: All treated participants

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.

Outcome measures

Measure	Arm A1, Safety Lead-in n=19 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=19 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in Module B, Cohorts 2 through 5	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Progression-Free Survival (PFS), Cohort 5 Only	1.22 months Interval 1.08 to 1.31	1.61 months Interval 1.31 to 3.45	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)

Population: All treated participants in Cohort 1

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.

Progression is defined as:

• ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement
• Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids
• Any new lesion
• Clear clinical deterioration not attributable to other causes apart from the tumor
• Failure to return for evaluation as a result of death or deteriorating condition
• Clear progression of non-measurable disease

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in Module B, Cohorts 2 through 5	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Progression-Free Survival (PFS), Cohort 1 Only	6.21 Months Interval 3.75 to 6.54	4.53 Months Interval 2.99 to 6.44	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to up to 12 months after first dose

Population: All treated participants in Cohorts 1-4

Overall survival at 12 months (OS12) is defined as the percentage of participants who are alive at 12 months, measured as the survival rate at 12 months from Kaplan-Meier product limit cumulative probability.

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=15 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Overall Survival at 12 Months (OS12), Cohorts 1-4	47.3 Percentage of participants Interval 25.2 to 66.5	42.9 Percentage of participants Interval 21.9 to 62.3	37.5 Percentage of participants Interval 15.4 to 59.8	32.8 Percentage of participants Interval 10.5 to 57.6	38.9 Percentage of participants Interval 14.3 to 63.2	86.7 Percentage of participants Interval 56.4 to 96.5	41.7 Percentage of participants Interval 15.2 to 66.5	44.4 Percentage of participants Interval 13.6 to 71.9	—	—

SECONDARY outcome

Timeframe: From first dose to up to 6 months after first dose

Population: All treated participants in Cohorts 2-5

Progression-free survival at 6 months (PFS6) is defined as the percentage of participants who are progression free and alive at 6 months following first dose date, measured as the survival rate at 6 months from Kaplan-Meier product limit cumulative probability of progression free.

Progression is defined as:

• ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement
• Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids
• Any new lesion
• Clear clinical deterioration not attributable to other causes apart from the tumor
• Failure to return for evaluation as a result of death or deteriorating condition
• Clear progression of non-measurable disease

Outcome measures

Measure	Arm A1, Safety Lead-in n=16 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=15 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=15 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=19 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5	9.4 Percentage of participants Interval 0.7 to 31.8	14.3 Percentage of participants Interval 2.3 to 36.6	0 Percentage of participants Insufficient number of participants with events.	20.0 Percentage of participants Interval 4.9 to 42.4	20.0 Percentage of participants Interval 3.1 to 47.5	11.4 Percentage of participants Interval 0.6 to 39.5	5.3 Percentage of participants Interval 0.4 to 21.4	14.0 Percentage of participants Interval 2.8 to 34.1	—	—

SECONDARY outcome

Timeframe: From first dose to the date of death (up to approximately 55 months)

Population: All treated participants in Cohorts 2-5

Overall survival (OS) is defined as the time between date of first dose and the date of death for Cohorts 2-5.

Outcome measures

Measure	Arm A1, Safety Lead-in n=16 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=15 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=15 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=19 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Overall Survival (OS), Cohorts 2-5	6.67 Months Interval 2.99 to 14.62	6.47 Months Interval 2.14 to 13.17	7.36 Months Interval 2.46 to 30.23	22.21 Months Interval 13.77 to Insufficient number of participants with events.	5.70 Months Interval 1.81 to Insufficient number of participants with events.	9.82 Months Interval 2.5 to Insufficient number of participants with events..	5.91 Months Interval 1.97 to 7.98	8.48 Months Interval 3.45 to 17.28	—	—

SECONDARY outcome

Timeframe: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

Population: All treated participants

The number of treated participants who experienced an Adverse Event (AE) during the course of the study.

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

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=15 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=19 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Treated Participants With Adverse Events (AEs)	23 Participants	21 Participants	15 Participants	14 Participants	14 Participants	15 Participants	12 Participants	10 Participants	18 Participants	18 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

Population: All treated participants

The number of treated participants who experienced a Serious Adverse Event (SAE) during the course of the study.

SAE is defined as any untoward medical occurrence that, at any dose:

• Results in death
• Is life-threatening
• Requires inpatient hospitalization or causes prolongation of existing hospitalization
• Results in persistent or significant disability/incapacity
• Is a congenital anomaly/birth defect
• Is an important medical event

Note: The reporting timeframe of the SAEs for this Outcome Measure (first dose to 30 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the AE section of the results form (first dose to 100 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=15 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=19 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Treated Participants With Serious Adverse Events (SAEs)	10 Participants	14 Participants	10 Participants	9 Participants	6 Participants	7 Participants	7 Participants	5 Participants	13 Participants	14 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

Population: All treated participants

The number of treated participants who experienced a Drug-Related Adverse Event during the course of the study.

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

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=15 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=19 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Treated Participants With Drug-Related Adverse Events	14 Participants	16 Participants	12 Participants	8 Participants	6 Participants	11 Participants	6 Participants	6 Participants	11 Participants	10 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

Population: All treated participants

The number of treated participants who experienced an Adverse Event leading to discontinuation during the course of the study.

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

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=15 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=19 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Treated Participants With Adverse Events Leading to Discontinuation	4 Participants	7 Participants	3 Participants	5 Participants	2 Participants	3 Participants	6 Participants	1 Participants	6 Participants	8 Participants

SECONDARY outcome

Timeframe: From first dose to the date of death (up to approximately 55 months)

Population: All treated participants

The number of treated participants who died during the course of the study.

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=15 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=19 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Treated Participant Deaths	18 Participants	18 Participants	12 Participants	13 Participants	12 Participants	11 Participants	9 Participants	7 Participants	18 Participants	15 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

Population: All treated participants

The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.

Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Units per Liter (U/L) Results reported in International System of Units (SI)

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=21 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=16 Participants Module B, Cohorts 2 through 5	Arm B3 n=12 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=13 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=14 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=11 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=18 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Treated Participant With Laboratory Abnormalities - Liver ALT OR AST > 3XULN	3 Participants	7 Participants	2 Participants	0 Participants	0 Participants	3 Participants	1 Participants	1 Participants	3 Participants	2 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver ALT OR AST > 5XULN	2 Participants	4 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver ALT OR AST > 10XULN	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	2 Participants	2 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver ALT OR AST > 20XULN	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver TOTAL BILIRUBIN > 2XULN	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver ALP > 1.5XULN	0 Participants	0 Participants	0 Participants	—	—	—	—	—	0 Participants	1 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver ALT or AST > 3xULN w/ Tbili > 1.5*ULN within 1 day	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver ALT or AST > 3xULN w/ Tbili > 1.5*ULN within 30 days	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver ALT or AST > 3xULN w/ Tbili > 2*ULN within 1 day	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Treated Participant With Laboratory Abnormalities - Liver ALT or AST > 3xULN w/ Tbili > 2*ULN within 30 days	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)

Population: All treated participants with at least one on-treatment TSH measurement

The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study.

Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Milliunits per Liter (mlU/L) Results reported in International System of Units (SI)

Outcome measures

Measure	Arm A1, Safety Lead-in n=20 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=20 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=10 Participants Module B, Cohorts 2 through 5	Arm B3 n=8 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=8 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=13 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 n=9 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=8 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=11 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=14 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH > ULN	2 Participants	1 Participants	3 Participants	1 Participants	3 Participants	7 Participants	2 Participants	3 Participants	1 Participants	5 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH > ULN, WITH TSH <= ULN AT BASELINE	2 Participants	1 Participants	2 Participants	1 Participants	0 Participants	7 Participants	1 Participants	3 Participants	1 Participants	2 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH > ULN, WITH AT LEAST ONE FT3/FT4 TEST < LLN	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	6 Participants	2 Participants	2 Participants	0 Participants	2 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH > ULN, WITH ALL OTHER FT3/FT4 TEST >= LLN	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH > ULN, WITH FT3/FT4 TEST MISSING	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH < LLN	3 Participants	7 Participants	2 Participants	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH < LLN, WITH TSH >= LLN AT BASELINE	3 Participants	6 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH<LLN, LLN WITH AT LEAST ONE FT3/FT4 TEST>ULN	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH < LLN, WITH ALL OTHER FT3/FT4 TEST <= ULN	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Treated Participant With Laboratory Abnormalities - Thyroid TSH < LLN, WITH FT3/FT4 TEST MISSING	2 Participants	4 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

POST_HOC outcome

Timeframe: From first dose to the date of death (up to approximately 55 months)

Population: All treated participants in Cohort 1

Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 17-Jan-2022).

Outcome measures

Measure	Arm A1, Safety Lead-in n=23 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=22 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in Module B, Cohorts 2 through 5	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Overall Survival (OS), Cohort 1 Only - Extended Collection	11.66 Months Interval 10.32 to 23.49	10.78 Months Interval 9.13 to 15.77	—	—	—	—	—	—	—	—

POST_HOC outcome

Timeframe: From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)

Population: All treated participants in Cohorts 2-4

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 17-Jan-2022).

Progression is defined as:

• ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement
• Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids
• Any new lesion
• Clear clinical deterioration not attributable to other causes apart from the tumor
• Failure to return for evaluation as a result of death or deteriorating condition
• Clear progression of non-measurable disease

Outcome measures

Measure	Arm A1, Safety Lead-in n=16 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=15 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in n=15 Participants Module B, Cohorts 2 through 5	Arm B3 n=15 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=12 Participants Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 Participants Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Progression-Free Survival (PFS), Cohorts 2-4 - Extended Collection	1.74 Months Interval 1.35 to 2.73	1.38 Months Interval 1.22 to 1.48	1.38 Months Interval 1.22 to 1.38	2.69 Months Interval 1.48 to 4.53	1.41 Months Interval 1.38 to 2.6	4.60 Months Interval 1.41 to 5.39	—	—	—	—

POST_HOC outcome

Timeframe: From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)

Population: All treated participants in Cohort 5

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 17-Jan-2022).

Progression is defined as:

• ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement
• Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids
• Any new lesion
• Clear clinical deterioration not attributable to other causes apart from the tumor
• Failure to return for evaluation as a result of death or deteriorating condition
• Clear progression of non-measurable disease

Outcome measures

Measure	Arm A1, Safety Lead-in n=19 Participants Module A, Cohort 1	Arms A2-A5, Safety Lead-in n=19 Participants Module A, Cohorts 2 through 5	Arms B2-B5, Safety Lead-in Module B, Cohorts 2 through 5	Arm B3 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A4 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Progression-Free Survival (PFS), Cohort 5 Only - Extended Collection	1.22 Months Interval 1.08 to 1.31	1.61 Months Interval 1.31 to 3.45	—	—	—	—	—	—	—	—

Adverse Events

Arm A1

Serious events: 17 serious events

Other events: 22 other events

Deaths: 18 deaths

Arm B1

Serious events: 16 serious events

Other events: 21 other events

Deaths: 18 deaths

Arm A2

Serious events: 13 serious events

Other events: 15 other events

Deaths: 12 deaths

Arm B2

Serious events: 12 serious events

Other events: 14 other events

Deaths: 13 deaths

Arm A3

Serious events: 7 serious events

Other events: 14 other events

Deaths: 12 deaths

Arm B3

Serious events: 10 serious events

Other events: 14 other events

Deaths: 11 deaths

Arm A4

Serious events: 11 serious events

Other events: 11 other events

Deaths: 9 deaths

Arm B4

Serious events: 6 serious events

Other events: 10 other events

Deaths: 7 deaths

Arm A5

Serious events: 14 serious events

Other events: 18 other events

Deaths: 18 deaths

Arm B5

Serious events: 15 serious events

Other events: 18 other events

Deaths: 15 deaths

Serious adverse events

Measure	Arm A1 n=23 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm B1 n=22 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm A2 n=16 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm B2 n=15 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm A3 n=15 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm B3 n=15 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=12 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=19 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Blood and lymphatic system disorders Anaemia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Vision blurred	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Abdominal pain	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Ascites	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Colitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Constipation	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Diarrhoea	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Enterocolitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Gastric ulcer	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Gastritis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Nausea	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Pancreatitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Vomiting	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Fatigue	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders General physical health deterioration	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Pyrexia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Respiratory tract infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Hepatobiliary disorders Autoimmune hepatitis	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Hepatobiliary disorders Hepatitis	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Hepatobiliary disorders Hepatitis acute	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Immune system disorders Hypersensitivity	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Immune system disorders Immune-mediated adverse reaction	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Immune system disorders Multisystem inflammatory syndrome in children	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Bacterial infection	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Coronavirus infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Device related infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Diarrhoea infectious	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Escherichia urinary tract infection	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Gastroenteritis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Measles	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Pneumonia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Sepsis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Staphylococcal infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Tonsillitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Shunt malfunction	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Upper respiratory tract infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Urinary tract infection	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Vascular device infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Wound infection staphylococcal	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Alanine aminotransferase increased	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Aspartate aminotransferase increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Chest X-ray abnormal	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Gamma-glutamyltransferase increased	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Hepatic enzyme increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Dehydration	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypophagia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Headache	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Steroid diabetes	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Muscular weakness	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Spinal deformity	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	39.1% 9/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	31.8% 7/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	37.5% 6/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	33.3% 5/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	40.0% 6/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	58.3% 7/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	50.0% 5/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	36.8% 7/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	36.8% 7/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour flare	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Dizziness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Dysarthria	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Dyskinesia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Facial nerve disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Haemorrhage intracranial	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Hemiparesis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Hydrocephalus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.2% 4/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	25.0% 3/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Intracranial pressure increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Lethargy	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Motor dysfunction	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Myoclonus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Nervous system disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Neurological decompensation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Paraesthesia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Partial seizures	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Seizure	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Somnolence	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Status epilepticus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Transient ischaemic attack	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Delirium	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Psychotic disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Bladder dysfunction	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Urinary incontinence	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Rash	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Hypertension	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Hypotension	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.

Other adverse events

Measure	Arm A1 n=23 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm B1 n=22 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 1: participants with newly-diagnosed DIPG, including midline glioma with H3K27M mutation.	Arm A2 n=16 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm B2 n=15 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 2: participants with recurrent or progressive non-brainstem HGG, regardless of mutation status, including glioblastoma.	Arm A3 n=15 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm B3 n=15 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 3: participants with relapsed or resistant medulloblastoma.	Arm A4 n=12 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 4: participants with relapsed or resistant ependymoma.	Arm B4 n=10 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 4: participants with relapsed or resistant ependymoma.	Arm A5 n=19 participants at risk Module A: nivolumab 3 mg/kg every 2 weeks. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).	Arm B5 n=19 participants at risk Module B: nivolumab 3 mg/kg + ipilimumab 1 mg/kg every 3 weeks, for 4 doses, then nivolumab 3 mg/kg every 2 weeks thereafter. Cohort 5: participants with other recurrent subtypes of high-grade CNS malignancy (eg, pineoblastoma, AT/RT, germ cell tumor, and others).
Eye disorders Eyelid oedema	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Blood and lymphatic system disorders Anaemia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Blood and lymphatic system disorders Leukopenia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Blood and lymphatic system disorders Lymphopenia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Blood and lymphatic system disorders Neutropenia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Cardiac disorders Sinus bradycardia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Cardiac disorders Sinus tachycardia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Cardiac disorders Tachycardia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Congenital, familial and genetic disorders Von Willebrand's disease	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Ear and labyrinth disorders Deafness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Ear and labyrinth disorders Ear pain	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Ear and labyrinth disorders Ear pruritus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Ear and labyrinth disorders Motion sickness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Ear and labyrinth disorders Tinnitus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Ear and labyrinth disorders Vertigo	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Endocrine disorders Cushingoid	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Endocrine disorders Diabetes insipidus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Endocrine disorders Hyperthyroidism	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Endocrine disorders Hypothyroidism	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Blepharospasm	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Blindness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Conjunctival hyperaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Corneal epithelium defect	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Diplopia	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Dry eye	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eye discharge	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eye haemorrhage	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eye inflammation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eye irritation	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eye movement disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eye pain	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eye swelling	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eyelid function disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Eyelid ptosis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Lacrimation increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Mydriasis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Ocular hyperaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Photophobia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Pupillary reflex impaired	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Eye disorders Vision blurred	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Facial pain	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Abdominal distension	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Abdominal pain	17.4% 4/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	31.8% 7/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Anal erythema	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Anal fissure	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Anal incontinence	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Chronic gastritis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Colitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Constipation	21.7% 5/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	22.7% 5/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	31.2% 5/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	33.3% 5/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Diarrhoea	26.1% 6/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	25.0% 4/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	25.0% 3/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Dry mouth	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Duodenitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Dyspepsia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Dysphagia	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.2% 4/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Flatulence	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Gastric ulcer	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Gastritis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Dysphemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Lip swelling	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Loose tooth	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Mouth ulceration	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Nausea	34.8% 8/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.2% 4/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	25.0% 4/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	33.3% 4/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Periodontal disease	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Post-tussive vomiting	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Proctalgia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Salivary hypersecretion	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Stomatitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Tongue oedema	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Toothache	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Gastrointestinal disorders Vomiting	34.8% 8/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	50.0% 11/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	43.8% 7/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	41.7% 5/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	40.0% 4/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	42.1% 8/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	52.6% 10/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Application site pruritus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Asthenia	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Chills	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Device related thrombosis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Fatigue	34.8% 8/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	27.3% 6/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	25.0% 4/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Gait disturbance	17.4% 4/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders General physical health deterioration	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Generalised oedema	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Hypothermia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Influenza like illness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Mucosal inflammation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Non-cardiac chest pain	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Oedema peripheral	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Pain	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Pyrexia	21.7% 5/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	27.3% 6/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	25.0% 3/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Sensation of foreign body	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
General disorders Xerosis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Hepatobiliary disorders Hepatitis acute	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Immune system disorders Drug hypersensitivity	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Immune system disorders Hypersensitivity	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Immune system disorders Infusion related hypersensitivity reaction	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Immune system disorders Seasonal allergy	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Bronchitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Catheter site infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Clostridium difficile infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Ear infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Enterobiasis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Eye infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Febrile infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Fungal skin infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Gastroenteritis	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Gastroenteritis Escherichia coli	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Herpes zoster	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Infection parasitic	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Influenza	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Lip infection	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Localised infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Nasopharyngitis	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Oral candidiasis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Oral herpes	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Otitis externa	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Otitis media	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Paronychia	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Pneumococcal infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Pneumonia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Postoperative wound infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Respiratory tract infection	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Respiratory tract infection viral	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Rhinitis	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Sepsis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Sinusitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Sinusitis bacterial	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Tooth abscess	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Upper respiratory tract infection	21.7% 5/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	30.0% 3/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Infections and infestations Urinary tract infection	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Contusion	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Fall	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Fracture	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood bicarbonate increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Head injury	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Mouth injury	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Shunt malfunction	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Stoma site discharge	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Tongue injury	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Vascular access complication	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Vascular access site discharge	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Vascular access site pain	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Insomnia	17.4% 4/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Vascular access site rash	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Injury, poisoning and procedural complications Wound	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Alanine aminotransferase increased	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	27.3% 6/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Amylase increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Anion gap increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Aspartate aminotransferase increased	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.2% 4/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	33.3% 5/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood alkaline phosphatase increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood chloride decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood creatine increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood creatinine decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood creatinine increased	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood lactate dehydrogenase decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood lactate dehydrogenase increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood magnesium decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood sodium increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood urea increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Blood uric acid increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Gamma-glutamyltransferase increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Haematocrit decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Haemoglobin decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Intestinal transit time increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Lipase increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Liver function test increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Lymphocyte count decreased	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Mean cell volume decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Mean cell volume increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Neutrophil count decreased	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Neutrophil count increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Platelet count decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Red blood cell count decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Red blood cell count increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Skin turgor decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Thyroxine free decreased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Thyroxine free increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Transaminases increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Tri-iodothyronine free increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Weight decreased	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	31.8% 7/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations Weight increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations White blood cell count decreased	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations White blood cell count increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Investigations White blood cells urine positive	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Acidosis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Decreased appetite	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.2% 4/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.8% 3/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Dehydration	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Fluid retention	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hyperammonaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypoglycaemia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypokalaemia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hyponatraemia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Hypophosphataemia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	31.6% 6/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Metabolism and nutrition disorders Polydipsia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Back pain	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Dactylitis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Mastication disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Muscle spasms	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Muscular weakness	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Irritability	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Pain in extremity	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Allodynia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Altered state of consciousness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Amnesia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Aphasia	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Areflexia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Ataxia	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	27.3% 6/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Balance disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Consciousness fluctuating	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Depressed level of consciousness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Diplegia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Hypoaesthesia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Disturbance in attention	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Dizziness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Dysarthria	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Epilepsy	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Facial nerve disorder	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Facial paralysis	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Facial paresis	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Haemorrhage intracranial	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Headache	39.1% 9/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	45.5% 10/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	43.8% 7/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	46.7% 7/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	40.0% 6/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	41.7% 5/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	68.4% 13/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.3% 5/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Hemianopia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Hemiparesis	17.4% 4/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	31.8% 7/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Hydrocephalus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Hypersomnia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders IIIrd nerve disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Intracranial pressure increased	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Lethargy	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Meningism	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Motor dysfunction	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Muscle spasticity	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Nervous system disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Neuralgia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Neuropathy peripheral	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Neurotoxicity	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Nystagmus	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Paraesthesia	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Paraparesis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Paresis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Partial seizures	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Presyncope	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Seizure	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	26.7% 4/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	15.8% 3/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Somnolence	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Speech disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Syncope	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Taste disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Tremor	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders Trigeminal nerve disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Nervous system disorders VIth nerve disorder	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Anxiety	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Behaviour disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Confusional state	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 2/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Depression	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Mood swings	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Phonophobia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Restlessness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Sleep disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Psychiatric disorders Suicidal ideation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Dysuria	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Haematuria	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Micturition urgency	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Neurogenic bladder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Nocturia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Oliguria	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Urinary hesitation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Urinary incontinence	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Renal and urinary disorders Urinary retention	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Reproductive system and breast disorders Testicular pain	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Cough	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.2% 4/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.8% 3/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	25.0% 3/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	21.1% 4/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	31.6% 6/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Dysphonia	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Epistaxis	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Productive cough	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Acne	8.7% 2/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Alopecia	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Blister	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Circumoral oedema	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.6% 3/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Eczema	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Erythema	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Keratosis pilaris	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Pruritus	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	9.1% 2/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	16.7% 2/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Rash	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	12.5% 2/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	13.3% 2/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Rash macular	13.0% 3/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	18.8% 3/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Rash papular	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Skin disorder	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Skin hypopigmentation	4.3% 1/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.0% 1/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Urticaria papular	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Skin and subcutaneous tissue disorders Xeroderma	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.2% 1/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Bloody discharge	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Deep vein thrombosis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Embolism	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Extremity necrosis	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Flushing	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	8.3% 1/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Hypertension	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	4.5% 1/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	20.0% 3/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	10.5% 2/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Vascular disorders Hypotension	0.00% 0/23 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/22 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/16 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	6.7% 1/15 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/12 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	0.00% 0/10 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.	5.3% 1/19 • All-cause mortality was assessed from first dose to study completion (up to approximately 55 months). SAEs and Other AEs were monitored from first dose to 100 days after last dose (up to an average of 5 months and to a maximum of 53 months). Note: The reporting timeframe of the below SAEs (first dose to 100 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the Outcome Measures section of the results form (first dose to 30 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email:

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60