Trial Outcomes & Findings for A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy (NCT NCT02677922)

NCT ID: NCT02677922

Last Updated: 2025-04-23

Results Overview

Dose-limiting toxicities (DLTs) are defined as an event that constitute a change from baseline irrespective of outcome and determined by the investigator to be related to treatment. The DLT-evaluable participants were defined as participants who took at least 1 dose of study drug in the Phase 1b Dose-Finding Stage and either had a DLT during Cycle 1 (regardless of amount of study drug exposure), or had no DLT and completed at least 75% of AG-120 or AG-221 doses (21 out of 28 days) and a minimum of 5 doses of AZA, at least 50% of the planned combination doses for AG-120 or AG-221 and AZA administered together (in the same day for 4 out of 7 days) in the first 28 days from C1D1, and were also considered by the Clinical Study Team to have sufficient safety data available to conclude that a DLT did not occur during Cycle 1.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1/PHASE2
• Target enrollment: 130 participants
• Primary outcome timeframe: From first dose to 28 days after first dose
• Results posted on: 2025-04-23

Participant Flow

Participant milestones

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AG-221 (100mg) + AZA Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AZA Monotherapy Azacitidine monotherapy was administered SC at 75 mg/m2/day for 7 days of every 28-day treatment cycle
Pre-Treatment Period STARTED	3	3	7	16	68	33
Pre-Treatment Period COMPLETED	3	3	7	16	68	32
Pre-Treatment Period NOT COMPLETED	0	0	0	0	0	1
Treatment Period STARTED	3	3	7	16	68	32
Treatment Period COMPLETED	1	1	4	3	21	1
Treatment Period NOT COMPLETED	2	2	3	13	47	31

Reasons for withdrawal

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AG-221 (100mg) + AZA Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AZA Monotherapy Azacitidine monotherapy was administered SC at 75 mg/m2/day for 7 days of every 28-day treatment cycle
Pre-Treatment Period Withdrawal by Subject	0	0	0	0	0	1
Treatment Period Adverse Event	0	0	1	3	5	2
Treatment Period Progressive Disease	1	1	0	0	8	7
Treatment Period Lack of Efficacy	0	0	0	1	1	6
Treatment Period Withdrawal by Subject	0	0	1	3	5	5
Treatment Period Transition to Commercially Available Treatment	0	1	1	1	1	2
Treatment Period Disease Relapse	0	0	0	3	6	1
Treatment Period Allogeneic HSCT	1	0	0	1	4	1
Treatment Period Other Reasons	0	0	0	1	3	5
Treatment Period Death	0	0	0	0	12	1
Treatment Period Non-compliance with Study Drug	0	0	0	0	1	0
Treatment Period Physician Decision	0	0	0	0	0	1
Treatment Period Symptomatic Deterioration	0	0	0	0	1	0

Baseline Characteristics

A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Baseline characteristics by cohort

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA n=7 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA n=16 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AG-221 (100mg) + AZA n=68 Participants Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AZA Monotherapy n=33 Participants Azacitidine monotherapy was administered SC at 75 mg/m2/day for 7 days of every 28-day treatment cycle	Total n=130 Participants Total of all reporting groups
Age, Customized < 65	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants	1 Participants n=10 Participants	12 Participants n=115 Participants
Age, Customized >= 65-< 75	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	22 Participants n=21 Participants	14 Participants n=10 Participants	47 Participants n=115 Participants
Age, Customized >= 75	2 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	39 Participants n=21 Participants	18 Participants n=10 Participants	71 Participants n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants	36 Participants n=21 Participants	11 Participants n=10 Participants	63 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	32 Participants n=21 Participants	22 Participants n=10 Participants	67 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants	51 Participants n=21 Participants	26 Participants n=10 Participants	103 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 Participants	6 Participants n=10 Participants	24 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	8 Participants n=115 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	13 Participants n=4 Participants	49 Participants n=21 Participants	24 Participants n=10 Participants	97 Participants n=115 Participants
Race (NIH/OMB) More than one race	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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants	7 Participants n=10 Participants	22 Participants n=115 Participants

PRIMARY outcome

Timeframe: From first dose to 28 days after first dose

Population: All DLT evaluable participants in the Phase 1b (Dose-finding Stage)

Dose-limiting toxicities (DLTs) are defined as an event that constitute a change from baseline irrespective of outcome and determined by the investigator to be related to treatment. The DLT-evaluable participants were defined as participants who took at least 1 dose of study drug in the Phase 1b Dose-Finding Stage and either had a DLT during Cycle 1 (regardless of amount of study drug exposure), or had no DLT and completed at least 75% of AG-120 or AG-221 doses (21 out of 28 days) and a minimum of 5 doses of AZA, at least 50% of the planned combination doses for AG-120 or AG-221 and AZA administered together (in the same day for 4 out of 7 days) in the first 28 days from C1D1, and were also considered by the Clinical Study Team to have sufficient safety data available to conclude that a DLT did not occur during Cycle 1.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA n=7 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
The Number of Participants Experiencing Dose-limiting Toxicities (DLTs): Phase 1B (Dose Finding Stage)	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: From first dose to 28 days after last dose (up to approximately 13 months)

Population: All treated participants in Phase 1B (Dose Finding and Expansion Stage)

The number of participants experiencing different types of adverse events (AE). An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A Serious Adverse Event (SAE) is any AE occurring at any dose that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or constitutes an important medical event. Adverse events were analyzed in terms of treatment-emergent AEs (TEAEs). Treatment-emergent adverse events (TEAE) was defined as events that began on or after the start of study drug through 28 days after the last study treatment. The severity/intensity of AEs were graded based upon the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03) where Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA n=7 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA n=16 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One TEAE Leading to Dose Reduction of Study Drug(s)	1 Participants	1 Participants	2 Participants	5 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One TEAE Leading to Dose Interruption of Study Drug(s)	3 Participants	3 Participants	2 Participants	11 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One Study Drug(s) Related TEAE Leading to Study Drug Dose Reduction	0 Participants	1 Participants	1 Participants	5 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One Study Drug(s) Related TEAE Leading to Study Drug Dose Interruption	1 Participants	2 Participants	2 Participants	8 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One TEAE	3 Participants	3 Participants	7 Participants	16 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One TEAE Related to Study Drug(s)	3 Participants	3 Participants	7 Participants	16 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One Grade 3-4 TEAE	3 Participants	3 Participants	7 Participants	15 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at least One Grade 3-4 TEAE Related to Study Drug(s)	2 Participants	2 Participants	4 Participants	10 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One Grade 5 TEAE	0 Participants	1 Participants	1 Participants	2 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One Grade 5 TEAE Related to Study Drug(s)	0 Participants	0 Participants	0 Participants	0 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One Serious TEAE	3 Participants	2 Participants	4 Participants	11 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One Serious TEAE Related to Study Drug(s)	0 Participants	1 Participants	1 Participants	5 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One TEAE Leading to Discontinuation of Study Drug(s)	1 Participants	0 Participants	1 Participants	4 Participants
The Number of Participants Experiencing Adverse Events: Phase 1B (Dose Finding and Expansion Stage) Participants with at Least One Study Drug Related TEAE Leading to Discontinuation of Study Drug	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From first dose up to approximately 26 months

Population: All randomized participants in Phase 2 (Randomized Stage)

The percent of participants with MLFS + CR + CRi + CRp + PR according to modified International Working Group Acute Myeloid Leukemia (IWG AML) response criteria as assessed by investigator. Complete response (CR) and morphologic leukemia-free state (MLFS) are defined as <5% blasts in a BM aspirate sample with marrow spicules and a count of ≥200 nucleated cells. There should be no blasts with Auer rods and no extramedullary disease. CR must also include: absolute neutrophil count (ANC) ≥1,000/μL, Platelet count ≥100,000/μL, and independent of red cell transfusions for ≥1 week before each response assessment. Complete remission with incomplete neutrophil recovery (CRi) is all criteria of CR except ANC. Complete remission with incomplete platelet recovery (CRp) is all criteria of CR except platelet count. Partial remission (PR) is defined as all hematologic criteria of CR with a >50% decrease in the percentage of BM blasts to 5% to 25%. (<5% considered if Auer rods are present).

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=68 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=33 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Overall Response Rate: Phase 2 (Randomized Stage)	73.5 Percent of Participants Interval 61.4 to 83.5	36.4 Percent of Participants Interval 20.4 to 54.9	—	—

SECONDARY outcome

Timeframe: From first dose up to approximately 13 months

Population: All treated participants in Phase 1B (Dose Finding and Expansion Stage)

Percent of participants with MLFS + CR + CRi + CRp + PR according to modified International Working Group Acute Myeloid Leukemia (IWG AML) response criteria as assessed by investigator. Complete response (CR) and morphologic leukemia-free state (MLFS) are defined as <5% blasts in a BM aspirate sample with marrow spicules and a count of ≥200 nucleated cells. There should be no blasts with Auer rods and no extramedullary disease. CR must also include: absolute neutrophil count (ANC) ≥1,000/μL, Platelet count ≥100,000/μL, and independent of red cell transfusions for ≥1 week before each response assessment. Complete remission with incomplete neutrophil recovery (CRi) is all criteria of CR except ANC. Complete remission with incomplete platelet recovery (CRp) is all criteria of CR except platelet count. Partial remission (PR) is defined as all hematologic criteria of CR with a >50% decrease in the percentage of BM blasts to 5% to 25%. (<5% considered if Auer rods are present).

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA n=7 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA n=16 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Overall Response Rate: Phase 1B (Dose Finding and Expansion Stage)	66.7 Percent of Participants Interval 9.4 to 99.2	66.7 Percent of Participants Interval 9.4 to 99.2	100 Percent of Participants Interval 59.0 to 100.0	68.8 Percent of Participants Interval 41.3 to 89.0

SECONDARY outcome

Timeframe: From first dose up to approximately 13 months

Population: All treated participants in Phase 1B (Dose Finding and Expansion Stage)

The percent of participants with morphologic complete remission (CR) and morphologic complete remission with partial hematologic recovery (CRh) based on laboratory data. CR is defined as less than 5% blasts in a BM aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods and absence of extramedullary disease. Plus, all the following conditions should be met: ANC ≥ 1 x 109/L (1,000/μL), platelet count ≥ 100 x 109/L (100,000/μL), independent of red cell transfusions for ≥ 1 week immediately before each response assessment. CRh is defined as less than 5% blasts in a BM aspirate sample with marrow spicules plus ANC > 500 x 109/L (1,000/μL) & Platelet count > 50 x 109/L (100,000/μL). CRh is defined as Response of bone marrow blast <5% with absolute neutrophil count (ANC) > 0.5 × 10^9/L and platelet > 50 × 10^9/L.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=3 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA n=7 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA n=16 Participants Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Sponsor Derived CR and CRh: Phase 1B (Dose Finding and Expansion Stage)	66.7 Percent of Participants Interval 9.4 to 99.2	66.7 Percent of Participants Interval 9.4 to 99.2	71.4 Percent of Participants Interval 29.0 to 96.3	62.5 Percent of Participants Interval 35.4 to 84.8

SECONDARY outcome

Timeframe: From randomization to the date of documented relapse, progression, or death due to any cause, whichever occurs first (up to approximately 26 months)

Population: All randomized participants in Phase 2 (Randomized Stage)

Event-Free Survival is the time from date of randomization to the date of documented morphologic relapse, progression, or death from any cause, whichever occurs first. Morphologic Relapse is defined as either reappearance of ≥ 5% blasts in the BM not attributable to any other cause or the development of extramedullary disease. Progression is defined as a > 50% increase of BM blast count percentage from baseline to ≥ 20% for participants with 5 to 70% BM blasts at baseline or a doubling of absolute blast count in peripheral blood from baseline to ≥ 10 x 109/L (10,000/μL) for participants with > 70% BM blasts at baseline or the development of new extramedullary disease.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=68 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=33 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Event-free Survival (EFS): Phase 2 (Randomized Stage)	15.9 Months Interval 13.0 to Insufficient number of participants with events	11.9 Months Interval 8.2 to 15.5	—	—

SECONDARY outcome

Timeframe: From first dose to 28 days after last dose (up to approximately 26 months)

Population: All treated participants in Phase 2 (Randomized Stage)

The number of participants experiencing different types of adverse events (AE). An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A Serious Adverse Event (SAE) is any AE occurring at any dose that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or constitutes an important medical event. Adverse events were analyzed in terms of treatment-emergent AEs (TEAEs). Treatment-emergent adverse events (TEAE) was defined as events that began on or after the start of study drug through 28 days after the last study treatment. The severity/intensity of AEs were graded based upon the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03) where Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=68 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=32 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
The Number of Participants Experiencing Adverse Events: Phase 2 (Randomized Stage) Participants with at Least One TEAE	68 Participants	32 Participants	—	—
The Number of Participants Experiencing Adverse Events: Phase 2 (Randomized Stage) Participants with at Least One TEAE Related to Study Drug(s)	62 Participants	26 Participants	—	—
The Number of Participants Experiencing Adverse Events: Phase 2 (Randomized Stage) Participants with at Least One Grade 3-4 TEAE	68 Participants	31 Participants	—	—
The Number of Participants Experiencing Adverse Events: Phase 2 (Randomized Stage) Participants with at least One Grade 3-4 TEAE Related to Study Drug(s)	50 Participants	20 Participants	—	—
The Number of Participants Experiencing Adverse Events: Phase 2 (Randomized Stage) Participants with at Least One Grade 5 TEAE	15 Participants	2 Participants	—	—
The Number of Participants Experiencing Adverse Events: Phase 2 (Randomized Stage) Participants with at Least One Grade 5 TEAE Related to Study Drug(s)	0 Participants	0 Participants	—	—
The Number of Participants Experiencing Adverse Events: Phase 2 (Randomized Stage) Participants with at Least One Serious TEAE	64 Participants	25 Participants	—	—
The Number of Participants Experiencing Adverse Events: Phase 2 (Randomized Stage) Participants with at Least One Serious TEAE Related to Study Drug(s)	29 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: From first dose up to approximately 26 months

Population: All randomized participants in Phase 2 (Randomized Stage)

The percent of participants with morphologic complete remission (CR) according to modified International Working Group Acute Myeloid Leukemia Response Criteria (IWG AML). CR is defined as less than 5% blasts in a BM aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods and absence of extramedullary disease; plus the following conditions: absolute neutrophil count (ANC) ≥1,000/μL, Platelet count ≥100,000/μL, and independent of red cell transfusions for ≥1 week before each response assessment.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=68 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=33 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Complete Remission Rate: Phase 2 (Randomized Stage)	54.4 Percent of Participants Interval 41.9 to 66.5	12.1 Percent of Participants Interval 3.4 to 28.2	—	—

SECONDARY outcome

Timeframe: From first dose up to approximately 26 months

Population: All randomized participants in Phase 2 (Randomized Stage)

The percent of participants with hematologic improvement neutrophil response (HI-N) + hematologic improvement platelet response (HI-P) + hematologic improvement erythroid response (HI-E) according to the International Working Group for Myelodysplastic Syndromes for Hematologic Improvement (IWG MDS HI) criteria. HI-E is defined as a hemoglobin increase by ≥ 1.5 g/dL and a relevant reduction in units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. HI-P is defined as an absolute increase of ≥ 30 X 10^9/L for participants starting with > 20 X and an increase from < 20 X 10^9/L to > 20 X 10^9/L and by at least 100%. HI-N is defined as At least 100% increase and an absolute increase > 0.5 X 10^9/L.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=68 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=33 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Hematologic Improvement (HI) Rate: Phase 2 (Randomized Stage)	70.6 Percent of Participants Interval 58.3 to 81.0	57.6 Percent of Participants Interval 39.2 to 74.5	—	—

SECONDARY outcome

Timeframe: From first dose up to approximately 26 months

Population: All randomized participants in Phase 2 (Randomized Stage) who achieved CR/CRi/CRp/PR/MLFS

The time from first documented CR/CRi/CRp/PR/MLFS to documented morphologic relapse, progression, or death due to any cause, whichever occurred first. CR and MLFS are defined as <5% blasts in a BM aspirate sample with marrow spicules + a count of ≥200 nucleated cells with no blasts with Auer rods + no extramedullary disease. CR must also include: ANC ≥ 1,000/μL, Platelet count ≥100,000/μL, + independent of red cell transfusions for ≥1 week before assessment. CRi is all criteria of CR except ANC. CRp is all criteria of CR except platelet count. PR is defined as all hematologic criteria of CR with >50% decrease in BM blasts to 5%-25%. Relapse is defined as reappearance of ≥ 5% blasts in the BM not attributable to other cause or development of extramedullary disease. Progression is defined as > 50% increase of BM blast count from baseline to ≥ 20% or a doubling of absolute blast count in peripheral blood from baseline to ≥ 10,000/μL or development of new extramedullary disease.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=50 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=12 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Duration of Response: Phase 2 (Randomized Stage)	24.1 Months Interval 10.0 to Insufficient number of participants with events	9.9 Months Interval 5.5 to 13.6	—	—

SECONDARY outcome

Timeframe: From first dose to to first documented MLFS/CR/CRi/CRp/PR (up to approximately 26 months)

Population: All randomized participants in Phase 2 (Randomized Stage) who achieved CR/CRi/CRp/PR/MLFS

Time from first dose of study drug to first documented MLFS/CR/CRi/CRp/PR according to modified IWG AML response criteria. Complete remission (CR) and morphologic leukemia-free state (MLFS) are defined as <5% blasts in a BM aspirate sample with marrow spicules and a count of ≥200 nucleated cells. There should be no blasts with Auer rods and no extramedullary disease. CR must also include the following conditions: absolute neutrophil count (ANC) ≥1,000/μL, Platelet count ≥100,000/μL, and independent of red cell transfusions for ≥1 week before each response assessment. Complete remission with incomplete neutrophil recovery (CRi) is all criteria of CR except ANC. Complete remission with incomplete platelet recovery (CRp) is all criteria of CR except platelet count. partial remission (PR) is defined as all hematologic criteria of CR with a >50% decrease in the percentage of BM blasts to 5% to 25%. (<5% considered if Auer rods are present).

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=50 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=12 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Time to Response: Phase 2 (Randomized Stage)	3.05 Months Standard Deviation 2.551	3.42 Months Standard Deviation 1.720	—	—

SECONDARY outcome

Timeframe: From randomization to date of death (up to approximately 26 months)

Population: All randomized participants in Phase 2 (Randomized Stage)

Overall survival (OS) is defined as time from randomization to death due to any cause.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=68 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=33 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Overall Survival: Phase 2 (Randomized Stage)	22.0 Months Interval 14.6 to Insufficient number of participants with events	22.3 Months Interval 11.9 to Insufficient number of participants with events	—	—

SECONDARY outcome

Timeframe: From randomization to 1 year after randomization

Population: All randomized participants in Phase 2 (Randomized Stage)

The percent of participants alive at 1 year from randomization

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=68 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=33 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
One Year Survival Rate: Phase 2 (Randomized Stage)	72.2 Percent of Participants Interval 59.6 to 81.5	69.6 Percent of Participants Interval 49.6 to 82.9	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 2, 3, 4, 6, 8 hours post dose (± 10 minutes) on day 1 of cycle 1 and 2

Population: All AG-120 treated participants with available pharmacokinetic measurements in Phase 1B (Expansion Stage)

Area under the plasma concentration-time curve from time zero to 8 hours, calculated using the linear trapezoid rule.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=12 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
AUC (0-8)- Area Under the Plasma Concentration-Time Curve: Phase 1B (Expansion Stage) CYCLE 1 DAY 1	31952.4465 (h*ng/mL) Standard Deviation 16008.00412	—	—	—
AUC (0-8)- Area Under the Plasma Concentration-Time Curve: Phase 1B (Expansion Stage) CYCLE 2 DAY 1	44291.5504 (h*ng/mL) Standard Deviation 18806.17037	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 2, 3, 4, 6, 8 hours post dose (± 10 minutes) on day 1 of cycle 1 and 2

Population: All AG-120 treated participants with available pharmacokinetic measurements in Phase 1B (Expansion Stage)

Cmax: Maximum observed plasma concentration, obtained directly from the observed concentration versus time data

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=15 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Cmax- Maximum Observed Plasma Concentration: Phase 1B (Expansion Stage) CYCLE 1 DAY 1	6058.0 (ng/mL) Standard Deviation 2750.97	—	—	—
Cmax- Maximum Observed Plasma Concentration: Phase 1B (Expansion Stage) CYCLE 2 DAY 1	6340.7 (ng/mL) Standard Deviation 3191.00	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 2, 3, 4, 6, 8 hours post dose (± 10 minutes) on day 1 of cycle 1 and 2

Population: All AG-120 treated participants with available pharmacokinetic measurements in Phase 1B (Expansion Stage)

Tmax: Time of maximum observed plasma concentration, obtained directly from the observed concentration versus time data.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=15 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Tmax- Time of Maximum Observed Plasma Concentration: Phase 1B (Expansion Stage) CYCLE 1 DAY 1	3.0000 (h) Interval 0.5 to 8.067	—	—	—
Tmax- Time of Maximum Observed Plasma Concentration: Phase 1B (Expansion Stage) CYCLE 2 DAY 1	2.5000 (h) Interval 0.5 to 7.85	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 3, 4, 6, and 8 hours post dose (± 10 minutes) on day 1 of cycle 2

Population: All AG-221 treated participants with available pharmacokinetic measurements in Phase 2 (Randomized Stage)

Area under the plasma concentration-time curve from time zero to 8 hours, calculated using the linear trapezoid rule.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=16 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
AUC (0-8)- Area Under the Plasma Concentration-Time Curve: Phase 2 (Randomized Stage)	100302.8231 (h*ng/mL) Standard Deviation 61286.98611	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 3, 4, 6, 8, and 24 hours post dose (± 10 minutes) on day 1 of cycle 2

Population: All AG-221 treated participants with available pharmacokinetic measurements in Phase 2 (Randomized Stage)

AUC0-24: Area under the plasma concentration-time curve from time zero to 24 hours, calculated using the linear trapezoid rule.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=13 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
AUC (0-24)- Area Under the Plasma Concentration-Time Curve: Phase 2 (Randomized Stage)	285864.2637 (h*ng/mL) Standard Deviation 190300.31922	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 3, 4, 6, 8, and 24 hours post dose (± 10 minutes) on day 1 of cycle 2

Population: All AG-221 treated participants with available pharmacokinetic measurements in Phase 2 (Randomized Stage)

Cmax: Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=16 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Cmax- Maximum Observed Plasma Concentration: Phase 2 (Randomized Stage)	15965.0 (ng/mL) Standard Deviation 9663.47	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 3, 4, 6, 8, and 24 hours post dose (± 10 minutes) on day 1 of cycle 2

Population: All AG-221 treated participants with available pharmacokinetic measurements in Phase 2 (Randomized Stage)

Tmax: Time of maximum observed plasma concentration, obtained directly from the observed concentration versus time data.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=16 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Tmax- Time of Maximum Observed Plasma Concentration: Phase 2 (Randomized Stage)	2.5333 (h) Interval 0.0 to 23.917	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 1 Cycle 5

Population: All randomized participants with baseline and at least one post-baseline assessment in Phase 2 (Randomized Stage)

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is composed of 30 items that address general physical symptoms, physical functioning, fatigue and malaise, and social and emotional functioning. Subscale scores are transformed to a 0 to 100 scale, with higher scores on functional scales indicating better function and higher scores on symptom scales indicating worse symptoms. Baseline results are obtained just prior to the start of study treatment on Day 1 of Cycle 1 and will serve as the baseline values. EORTC QLQ-C30 is assessed prior to dosing and prior to interaction with study personnel.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=28 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=17 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Global QoL	12.2 Score on a scale Standard Deviation 27.36	4.9 Score on a scale Standard Deviation 27.33	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Physical functioning	1.9 Score on a scale Standard Deviation 20.6	6.7 Score on a scale Standard Deviation 23.57	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Role functioning	-0.6 Score on a scale Standard Deviation 29.57	1.0 Score on a scale Standard Deviation 30.88	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Cognitive functioning	-4.8 Score on a scale Standard Deviation 26.00	4.9 Score on a scale Standard Deviation 25.53	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Emotional functioning	7.7 Score on a scale Standard Deviation 24.42	8.8 Score on a scale Standard Deviation 18.51	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Social functioning	-6.5 Score on a scale Standard Deviation 29.52	6.9 Score on a scale Standard Deviation 34.89	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Fatigue	-17.5 Score on a scale Standard Deviation 33.05	-8.5 Score on a scale Standard Deviation 31.06	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Nausea and vomiting	-6.0 Score on a scale Standard Deviation 29.47	1.0 Score on a scale Standard Deviation 16.11	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Pain	-13.1 Score on a scale Standard Deviation 33.13	-4.9 Score on a scale Standard Deviation 30.48	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Dyspnea	-27.4 Score on a scale Standard Deviation 35.20	-9.8 Score on a scale Standard Deviation 28.30	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Insomnia	-6.0 Score on a scale Standard Deviation 25.75	-13.7 Score on a scale Standard Deviation 26.51	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Appetite loss	-7.1 Score on a scale Standard Deviation 42.90	-5.9 Score on a scale Standard Deviation 35.81	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Constipation	6.0 Score on a scale Standard Deviation 32.78	-9.8 Score on a scale Standard Deviation 22.87	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Diarrhea	-7.1 Score on a scale Standard Deviation 31.89	-5.9 Score on a scale Standard Deviation 29.43	—	—
Change From Baseline in Health-related Quality-of-Life Domain Scores of the EORTC QLQ-C30: Phase 2 (Randomized Stage) Financial difficulties	8.3 Score on a scale Standard Deviation 19.51	-2.0 Score on a scale Standard Deviation 34.30	—	—

SECONDARY outcome

Timeframe: Baseline and Day 1 Cycle 5

Population: All randomized participants with baseline and at least one post-baseline assessment in Phase 2 (Randomized Stage)

The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. These health states are converted to a single index value using the crosswalk method to the EQ-5D-3L value set from the United Kingdom (UK). The EQ-5D-3L health utility index based on the UK population weights range from -0.594 to 1.0 with higher scores indicating higher health utility. Baseline results are obtained just prior to the start of study treatment on Day 1 of Cycle 1 and will serve as the baseline values.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=28 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=14 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Change From Baseline in Health Utility Indices of the EQ-5D-5L: Phase 2 (Randomized Stage)	0.04 Score on a scale Standard Deviation 0.216	0.02 Score on a scale Standard Deviation 0.211	—	—

SECONDARY outcome

Timeframe: Baseline and Day 1 Cycle 5

Population: All randomized participants with baseline and at least one post-baseline assessment in Phase 2 (Randomized Stage)

The European Quality of Life 5D-5L (EQ-5D-5L) instrument has a respondent's self-rated today's health scale which is recorded on a VAS with endpoints labeled "the best health you can imagine" and "the worst health you can imagine." The scale is numbered from 0 to 100 with 0 corresponding to the worst imaginable health state and 100 corresponding to the best imaginable health state. A high score represents a better level of QoL. Baseline results are obtained just prior to the start of study treatment on Day 1 of Cycle 1 and will serve as the baseline values.

Outcome measures

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=28 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=17 Participants Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.
Change From Baseline in Visual Analogue Scale (VAS) Scores of the EQ-5D-5L: Phase 2 (Randomized Stage)	13.00 Score on a scale Standard Deviation 26.166	1.65 Score on a scale Standard Deviation 27.897	—	—

SECONDARY outcome

Timeframe: From first dose to end of study

The number of participants with Morphologic Complete Remission (CR) based on laboratory data. CR is defined as as less than 5% blasts in a BM aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods and absence of extramedullary disease. Plus, all the following conditions should be met: ANC ≥ 1 x 109/L (1,000/μL), platelet count ≥ 100 x 109/L (100,000/μL), independent of red cell transfusions for ≥ 1 week immediately before each response assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to end of study

The number of participants with morphologic complete remission (CR) and morphologic complete remission with partial hematologic recovery (CRh) based on laboratory data. CR is defined as less than 5% blasts in a BM aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods and absence of extramedullary disease. Plus, all the following conditions should be met: ANC ≥ 1 x 109/L (1,000/μL), platelet count ≥ 100 x 109/L (100,000/μL), independent of red cell transfusions for ≥ 1 week immediately before each response assessment. CRh is defined as Response of bone marrow blast <5% with absolute neutrophil count (ANC) > 0.5 × 10^9/L and platelet > 50 × 10^9/L.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to end of study

Time from first dose of study drug to first documented CR/CRh. Morphologic Complete Remission (CR) is defined as as less than 5% blasts in a BM aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods and absence of extramedullary disease. Plus, all the following conditions should be met: ANC ≥ 1 x 109/L (1,000/μL), platelet count ≥ 100 x 109/L (100,000/μL), independent of red cell transfusions for ≥ 1 week immediately before each response assessment. Morphologic complete remission with partial hematologic recovery (CRh) is defined as less than 5% blasts in a BM aspirate sample with marrow spicules plus ANC > 500 x 109/L (1,000/μL) & Platelet count > 50 x 109/L (100,000/μL).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to end of study

Time from first documented CR/CRh to documented morphologic relapse, PD, or death due to any cause, whichever occurred first. Participants without morphologic relapse, PD, or death due to any cause were censored at the date of the last response assessment. Morphologic Relapse is defined as either reappearance of ≥ 5% blasts in the BM not attributable to any other cause or the development of extramedullary disease. Progression (PD) is defined as a > 50% increase of BM blast count percentage from baseline to ≥ 20% for participants with 5 to 70% BM blasts at baseline or a doubling of absolute blast count in peripheral blood from baseline to ≥ 10 x 109/L (10,000/μL) for participants with > 70% BM blasts at baseline or the development of new extramedullary disease.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA

Serious events: 4 serious events

Other events: 7 other events

Deaths: 1 deaths

Phase 1b Expansion Stage: AG-120 (500mg) + AZA

Serious events: 11 serious events

Other events: 16 other events

Deaths: 6 deaths

Phase 2 Randomized Stage: AG-221 (100mg) + AZA

Serious events: 64 serious events

Other events: 67 other events

Deaths: 29 deaths

Phase 2 Randomized Stage: AZA Monotherapy

Serious events: 25 serious events

Other events: 32 other events

Deaths: 14 deaths

Serious adverse events

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=3 participants at risk Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=3 participants at risk Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA n=7 participants at risk Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA n=16 participants at risk Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AG-221 (100mg) + AZA n=68 participants at risk Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AZA Monotherapy n=32 participants at risk Azacitidine monotherapy was administered SC at 75 mg/m2/day for 7 days of every 28-day treatment cycle
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	43.8% 7/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	38.2% 26/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 8/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Hyperfibrinolysis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenic purpura	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Acute myocardial infarction	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrioventricular block complete	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Bundle branch block left	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac arrest	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Coronary artery disease	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Myocardial ischaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Pericardial haemorrhage	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypopituitarism	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Haemorrhoidal haemorrhage	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Large intestine perforation	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Salivary gland enlargement	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Volvulus of small bowel	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Catheter site thrombosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Death	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Fatigue	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders General physical health deterioration	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Influenza like illness	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Medical device site pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Non-cardiac chest pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Bile duct stone	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Cholecystitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Immune system disorders Hypersensitivity	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Anorectal infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bacteraemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bacterial sepsis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Cellulitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Chest wall abscess	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Clostridium difficile colitis	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Colonic abscess	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Coxsackie viral infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Cystitis bacterial	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Device related infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Device related sepsis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Diverticulitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Endocarditis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Enterobacter bacteraemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Enterococcal infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Gastroenteritis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Gastrointestinal infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Haemophilus sepsis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Injection site cellulitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Lower respiratory tract infection fungal	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Lung infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.3% 7/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Neutropenic infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Neutropenic sepsis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Oral infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Osteomyelitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Parainfluenzae virus infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Paronychia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.3% 7/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia bacterial	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia fungal	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia influenzal	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Rectal abscess	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Respiratory tract infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Scrotal abscess	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sepsis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.8% 8/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Septic shock	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Serratia bacteraemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Skin infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Soft tissue infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Staphylococcal infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Streptococcal bacteraemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Superinfection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Tooth abscess	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection bacterial	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection fungal	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urosepsis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Vascular device infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Hyphaema	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood bilirubin increased	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchioloalveolar carcinoma	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Differentiation syndrome	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.3% 7/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Altered state of consciousness	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Depressed level of consciousness	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Nervous system disorder	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Presyncope	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Seizure	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Syncope	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Transient ischaemic attack	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Mental status changes	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Azotaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Urinary retention	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Circulatory collapse	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Embolism	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypertension	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypertensive crisis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypotension	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Other adverse events

Measure	Phase 1b Dose-finding Stage: AG-221 (100mg) + AZA n=3 participants at risk Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100 mg orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-221 (200mg) + AZA n=3 participants at risk Participants with an IDH2 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 200 mg, orally QD on Days 1 to 28 of each 28-day cycle.	Phase 1b Dose-finding Stage: AG-120 (500mg) + AZA n=7 participants at risk Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 1b Expansion Stage: AG-120 (500mg) + AZA n=16 participants at risk Participants with an IDH1 mutation receive Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-120 tablets was given at 500 mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AG-221 (100mg) + AZA n=68 participants at risk Azacitidine SC 75 mg/m2/day for 7 days of every 28-day treatment cycle was co-administered with AG-221 tablets given at 100mg orally once a day (QD) on Days 1 to 28 of each 28-day cycle.	Phase 2 Randomized Stage: AZA Monotherapy n=32 participants at risk Azacitidine monotherapy was administered SC at 75 mg/m2/day for 7 days of every 28-day treatment cycle
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	100.0% 3/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	42.9% 3/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	43.8% 7/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	51.5% 35/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	46.9% 15/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Haemolysis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	45.6% 31/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.1% 9/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Splenomegaly	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Blood and lymphatic system disorders Thrombocytopenia	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	71.4% 5/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	43.8% 7/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	58.8% 40/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	43.8% 14/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrial flutter	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Atrioventricular block complete	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Bradycardia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiac failure	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Cardiomegaly	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Palpitations	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Pericarditis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Sinus arrhythmia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Supraventricular tachycardia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Cardiac disorders Tachycardia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Ear and labyrinth disorders Ear pain	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Lacrimation decreased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Periorbital swelling	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Vision blurred	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Eye disorders Visual impairment	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain	100.0% 3/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 4/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	17.6% 12/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Anal fistula	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Anal incontinence	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Colitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Constipation	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	57.1% 4/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	43.8% 7/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	45.6% 31/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	46.9% 15/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Defaecation urgency	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	71.4% 5/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	56.2% 9/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	42.6% 29/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.1% 9/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Dysphagia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Flatulence	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Gastritis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Ileus	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Lip swelling	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Melaena	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Nausea	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	85.7% 6/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	50.0% 8/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	69.1% 47/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	37.5% 12/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Oral disorder	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Proctalgia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Stomatitis	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.7% 10/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Toothache	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	100.0% 3/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	56.2% 9/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	48.5% 33/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	34.4% 11/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Asthenia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	23.5% 16/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Catheter site pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Chest discomfort	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Chest pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Chills	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Facial pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Fatigue	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	71.4% 5/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 4/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	27.9% 19/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 8/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Gait disturbance	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Granuloma	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Infusion site discomfort	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Infusion site reaction	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Injection site bruising	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Injection site erythema	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.2% 11/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	21.9% 7/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Injection site haemorrhage	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Injection site irritation	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Injection site pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Injection site pruritus	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Injection site reaction	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Injection site swelling	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Malaise	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Mucosal inflammation	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Non-cardiac chest pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Oedema peripheral	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 4/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	29.4% 20/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	31.2% 10/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Peripheral swelling	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Pyrexia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	31.2% 5/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	27.9% 19/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 6/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
General disorders Vessel puncture site haematoma	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Cholelithiasis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Granulomatous liver disease	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Immune system disorders Drug hypersensitivity	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Immune system disorders Immunodeficiency	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bacteraemia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Bacterial infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Conjunctivitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Device related sepsis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Enterococcal infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Folliculitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Fungal skin infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Influenza	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Lung infection	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Mastoiditis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Mycobacterium avium complex infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Nasopharyngitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Oral candidiasis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Oral herpes	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Paronychia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Periodontitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Pneumonia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Post procedural infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sepsis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Sinusitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Skin infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Staphylococcal infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	31.2% 5/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Urinary tract infection	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.2% 11/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Injury, poisoning and procedural complications Wound	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Amylase increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Antithrombin III decreased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood bilirubin increased	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	100.0% 3/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	27.9% 19/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood chloride decreased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood cholesterol increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood creatinine increased	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood glucose increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood phosphorus increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Blood urea increased	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations C-reactive protein increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Carbon dioxide decreased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Carbon dioxide increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	43.8% 7/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations International normalised ratio increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Lipase increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Lymphocyte count decreased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Neutrophil count decreased	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Platelet count decreased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Transaminases increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations Weight decreased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations White blood cell count decreased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Investigations White blood cell count increased	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	31.2% 5/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	36.8% 25/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Fluid overload	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Gout	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperlipasaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypernatraemia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.3% 7/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypocalcaemia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	42.9% 3/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	31.2% 5/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	36.8% 25/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Vitamin B1 deficiency	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Metabolism and nutrition disorders Zinc deficiency	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.7% 10/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	37.5% 6/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	17.6% 12/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	10.3% 7/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.8% 8/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Differentiation syndrome	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Cognitive disorder	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dizziness	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	42.9% 3/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 17/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Dysgeusia	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Headache	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 4/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	20.6% 14/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	15.6% 5/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Hyperaesthesia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Hypersomnia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Lethargy	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Memory impairment	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Migraine with aura	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Paraesthesia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Restless legs syndrome	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Nervous system disorders Tremor	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Pregnancy, puerperium and perinatal conditions Cephalhaematoma	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Anxiety	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.8% 8/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Claustrophobia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Confusional state	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Delirium	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Depression	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	18.8% 3/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Hallucination	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Insomnia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 4/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.1% 13/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Psychiatric disorders Panic attack	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	16.2% 11/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Chronic kidney disease	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Dysuria	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Haematuria	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Renal failure	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Renal and urinary disorders Urinary retention	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Reproductive system and breast disorders Prostatism	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Reproductive system and breast disorders Pruritus genital	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	28.6% 2/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	25.0% 4/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.1% 13/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	21.9% 7/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.1% 13/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 4/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	17.6% 12/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleural effusion	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Pleurisy	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Blister	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Ecchymosis	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 2/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	8.8% 6/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	4.4% 3/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	11.8% 8/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Skin discomfort	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	1.5% 1/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Aortic thrombosis	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Flushing	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Haematoma	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	5.9% 4/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	3.1% 1/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypertension	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	7.4% 5/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Hypotension	66.7% 2/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	12.5% 2/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	19.1% 13/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	9.4% 3/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Orthostatic hypotension	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	6.2% 1/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	2.9% 2/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Pallor	33.3% 1/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
Vascular disorders Thrombophlebitis superficial	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/3 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	14.3% 1/7 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/16 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/68 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.	0.00% 0/32 • From first dose up to approximately 26 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

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 Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER