Trial Outcomes & Findings for A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes (NCT NCT02848001)

NCT ID: NCT02848001

Last Updated: 2025-06-12

Results Overview

A participant evaluable for DLT is defined as one that: Has received at least 80% of the total planned Cycle 1 dose (eg, ≥ 4 CC-90009 doses for the Days 1-5 schedule to be completed on or before Day 10, ≥ 6 CC-90009 doses for the Days 1- 7 schedule to be completed on or before Day 10, ≥8 doses by Day 14 for the Days 1-10 schedule, or ≥ 5 doses by Day 14 for the D1-3/D8-10 schedule) of CC-90009 during Cycle 1 without experiencing a DLT, Or; Experienced a DLT after receiving at least one dose (or fraction thereof) of CC-90009 in part A.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 101 participants
• Primary outcome timeframe: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)
• Results posted on: 2025-06-12

Participant Flow

Participant milestones

Measure	Part A - 0.3 mg Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)	Part B - AML 2.4 mg Part B - AML CC-90009 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Overall Study STARTED	2	2	2	7	15	3	8	7	7	9	3	7	8	2	9	9	1
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Overall Study NOT COMPLETED	2	2	2	7	15	3	8	7	7	9	3	7	8	2	8	9	1

Reasons for withdrawal

Measure	Part A - 0.3 mg Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)	Part B - AML 2.4 mg Part B - AML CC-90009 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Overall Study other reasons	0	0	1	0	4	1	0	2	2	3	0	1	1	0	0	2	1
Overall Study Lack of Efficacy	0	1	1	2	3	0	1	0	0	1	0	2	0	2	2	0	0
Overall Study Progressive Disease	2	1	0	4	3	0	4	1	0	2	3	2	1	0	2	4	0
Overall Study Adverse Event	0	0	0	0	2	0	0	0	0	1	0	1	1	0	2	0	0
Overall Study Death	0	0	0	1	3	1	2	3	4	1	0	1	3	0	2	3	0
Overall Study Physician Decision	0	0	0	0	0	0	0	0	1	1	0	0	2	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	0	0	1	1	1	0	0	0	0	0	0	0	0	0

Baseline Characteristics

A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

Baseline characteristics by cohort

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - AML CC-90009 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)	Total n=101 Participants Total of all reporting groups
Age, Continuous	64.0 Years STANDARD_DEVIATION 8.49 • n=5 Participants	70.0 Years STANDARD_DEVIATION 11.31 • n=7 Participants	60.0 Years STANDARD_DEVIATION 8.49 • n=5 Participants	69.6 Years STANDARD_DEVIATION 8.81 • n=4 Participants	62.2 Years STANDARD_DEVIATION 10.47 • n=21 Participants	71.3 Years STANDARD_DEVIATION 6.81 • n=10 Participants	59.0 Years STANDARD_DEVIATION 20.20 • n=115 Participants	57.3 Years STANDARD_DEVIATION 17.76 • n=24 Participants	66.0 Years STANDARD_DEVIATION 7.05 • n=42 Participants	53.1 Years STANDARD_DEVIATION 18.20 • n=42 Participants	64.3 Years STANDARD_DEVIATION 15.28 • n=42 Participants	63.0 Years STANDARD_DEVIATION 17.01 • n=42 Participants	63.3 Years STANDARD_DEVIATION 4.43 • n=36 Participants	76.5 Years STANDARD_DEVIATION 2.12 • n=36 Participants	66.0 Years STANDARD_DEVIATION 11.05 • n=24 Participants	75.1 Years STANDARD_DEVIATION 7.25 • n=135 Participants	53.0 Years STANDARD_DEVIATION NA • n=136 Participants	63.9 Years STANDARD_DEVIATION 13.24 • n=44 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=36 Participants	0 Participants n=36 Participants	2 Participants n=24 Participants	4 Participants n=135 Participants	0 Participants n=136 Participants	33 Participants n=44 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	13 Participants n=21 Participants	2 Participants n=10 Participants	7 Participants n=115 Participants	4 Participants n=24 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=36 Participants	2 Participants n=36 Participants	7 Participants n=24 Participants	5 Participants n=135 Participants	1 Participants n=136 Participants	68 Participants n=44 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	2 Participants n=24 Participants	2 Participants n=135 Participants	0 Participants n=136 Participants	9 Participants n=44 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants	6 Participants n=24 Participants	7 Participants n=42 Participants	9 Participants n=42 Participants	3 Participants n=42 Participants	6 Participants n=42 Participants	7 Participants n=36 Participants	2 Participants n=36 Participants	6 Participants n=24 Participants	7 Participants n=135 Participants	1 Participants n=136 Participants	90 Participants n=44 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 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	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	5 Participants n=44 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	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	4 Participants n=44 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants	3 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=24 Participants	7 Participants n=42 Participants	8 Participants n=42 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	6 Participants n=36 Participants	2 Participants n=36 Participants	6 Participants n=24 Participants	7 Participants n=135 Participants	1 Participants n=136 Participants	79 Participants n=44 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	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=36 Participants	0 Participants n=36 Participants	2 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	13 Participants n=44 Participants

PRIMARY outcome

Timeframe: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)

Population: All treated participants in dose escalation (Part A)

A participant evaluable for DLT is defined as one that: Has received at least 80% of the total planned Cycle 1 dose (eg, ≥ 4 CC-90009 doses for the Days 1-5 schedule to be completed on or before Day 10, ≥ 6 CC-90009 doses for the Days 1- 7 schedule to be completed on or before Day 10, ≥8 doses by Day 14 for the Days 1-10 schedule, or ≥ 5 doses by Day 14 for the D1-3/D8-10 schedule) of CC-90009 during Cycle 1 without experiencing a DLT, Or; Experienced a DLT after receiving at least one dose (or fraction thereof) of CC-90009 in part A.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Number of Participants With Dose Limiting Toxicity (DLTs)	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)

Population: All treated participants in dose escalation (Part A)

The NTD is defined as a dose level at which 2 or more of up to 6 evaluable participants in any dose cohort experience a DLT in Cycle 1 during dose escalation (Part A)

Outcome measures

Measure	Part A - 0.3 mg n=72 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Non-Tolerated Dose (NTD) of CC-90009	4.5 mg	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose to at least 28 days and up to 42 days post first dose (Up to 42 days)

Population: All treated participants in dose escalation (Part A)

The MTD is defined as the last dose level(s) below the NTD with 0 or 1 out of 6 evaluable participants experiencing a DLT in Cycle 1 during dose escalation (part A).

Outcome measures

Measure	Part A - 0.3 mg n=72 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Maximum Tolerated Dose (MTD) of CC-90009	3.6 mg	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose until 28 days post last dose (Up to 25 months)

Population: All treated participants

An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Treatment-emergent adverse events (TEAEs) are defined as any AEs that begin on or after the start of study drug through 28 days after the last dose of study drug or serious AEs that are suspected of being related to study drug.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAE	2 Participants	2 Participants	2 Participants	7 Participants	15 Participants	3 Participants	8 Participants	7 Participants	7 Participants	9 Participants	3 Participants	7 Participants	8 Participants	2 Participants	9 Participants	9 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) TEAE related to CC-90009	2 Participants	0 Participants	2 Participants	6 Participants	13 Participants	3 Participants	8 Participants	7 Participants	7 Participants	9 Participants	3 Participants	7 Participants	8 Participants	2 Participants	7 Participants	7 Participants	1 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Serious TEAE	0 Participants	0 Participants	1 Participants	6 Participants	15 Participants	3 Participants	7 Participants	7 Participants	7 Participants	6 Participants	3 Participants	6 Participants	8 Participants	1 Participants	9 Participants	8 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Serious TEAE related to CC-90009	0 Participants	0 Participants	0 Participants	1 Participants	6 Participants	2 Participants	4 Participants	6 Participants	3 Participants	4 Participants	1 Participants	1 Participants	3 Participants	1 Participants	3 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline by Laboratory Test - Chemistry Parameters 1 Protein Maximum Post Baseline Value	8.5000 g/L Standard Deviation 6.36396	13.5000 g/L Standard Deviation 7.77817	4.5000 g/L Standard Deviation 4.94975	5.7143 g/L Standard Deviation 6.10230	122.8667 g/L Standard Deviation 449.87615	7.0000 g/L Standard Deviation 6.08276	6.8750 g/L Standard Deviation 7.07990	4.2857 g/L Standard Deviation 5.25085	2.1429 g/L Standard Deviation 4.41318	4.2222 g/L Standard Deviation 6.86982	7.3333 g/L Standard Deviation 4.93288	6.0000 g/L Standard Deviation 2.94392	0.1250 g/L Standard Deviation 4.61171	4.5000 g/L Standard Deviation 2.12132	5.7375 g/L Standard Deviation 4.72469	5.6250 g/L Standard Deviation 5.01248	13.0000 g/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 1 Albumin Minimum Post Baseline Value	-6.0000 g/L Standard Deviation 0.00000	0.0000 g/L Standard Deviation 1.41421	-9.5000 g/L Standard Deviation 2.12132	-3.9286 g/L Standard Deviation 3.27145	-9.8000 g/L Standard Deviation 6.82642	-11.3333 g/L Standard Deviation 2.51661	-7.7500 g/L Standard Deviation 4.65219	-12.2857 g/L Standard Deviation 6.29058	-9.8571 g/L Standard Deviation 4.74091	-9.3333 g/L Standard Deviation 3.57071	-7.6667 g/L Standard Deviation 4.04145	-6.5714 g/L Standard Deviation 3.99404	-9.6250 g/L Standard Deviation 5.73056	-14.5000 g/L Standard Deviation 12.02082	-4.2778 g/L Standard Deviation 4.29062	-5.9444 g/L Standard Deviation 2.55495	-2.0000 g/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 1 Albumin Maximum Post Baseline Value	6.5000 g/L Standard Deviation 4.94975	10.5000 g/L Standard Deviation 7.77817	2.0000 g/L Standard Deviation 2.82843	4.2143 g/L Standard Deviation 3.16039	1.7333 g/L Standard Deviation 7.43031	7.6667 g/L Standard Deviation 5.13160	4.6250 g/L Standard Deviation 3.20435	3.4286 g/L Standard Deviation 3.69040	2.7143 g/L Standard Deviation 4.23140	2.8889 g/L Standard Deviation 3.75648	4.3333 g/L Standard Deviation 1.52753	3.4286 g/L Standard Deviation 2.93582	1.6250 g/L Standard Deviation 3.11391	0.5000 g/L Standard Deviation 4.94975	5.0444 g/L Standard Deviation 2.56861	4.0778 g/L Standard Deviation 3.25645	8.0000 g/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 1 Protein Minimum Post Baseline Value	-11.0000 g/L Standard Deviation 5.65685	-1.0000 g/L Standard Deviation 4.24264	-13.0000 g/L Standard Deviation 1.41421	-9.7143 g/L Standard Deviation 5.31395	-12.8667 g/L Standard Deviation 4.43793	-20.6667 g/L Standard Deviation 9.50438	-12.2500 g/L Standard Deviation 5.39179	-16.5714 g/L Standard Deviation 3.86683	-18.4286 g/L Standard Deviation 5.19157	-16.8889 g/L Standard Deviation 8.00694	-12.0000 g/L Standard Deviation 3.60555	-9.8571 g/L Standard Deviation 4.84522	-16.7500 g/L Standard Deviation 8.11964	-16.0000 g/L Standard Deviation 8.48528	-10.6750 g/L Standard Deviation 3.67064	-10.7500 g/L Standard Deviation 5.06388	-3.0000 g/L Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline by Laboratory Test - Chemistry Parameters 2 Alkaline Phosphatase (Serum) Minimum Post Baseline Value	-23.0000 U/L Standard Deviation 16.97056	-4.5000 U/L Standard Deviation 4.94975	-26.7500 U/L Standard Deviation 20.85965	4.1429 U/L Standard Deviation 57.68428	-27.9333 U/L Standard Deviation 25.48520	-29.6667 U/L Standard Deviation 40.27820	-55.6250 U/L Standard Deviation 101.06142	-52.4286 U/L Standard Deviation 66.26678	-57.8571 U/L Standard Deviation 68.82448	-15.6667 U/L Standard Deviation 19.00000	-4.0000 U/L Standard Deviation 3.60555	-17.7143 U/L Standard Deviation 18.56264	-18.6250 U/L Standard Deviation 10.50085	-14.5000 U/L Standard Deviation 0.70711	-25.5222 U/L Standard Deviation 51.20380	-9.7778 U/L Standard Deviation 12.80408	-12.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 2 Alkaline Phosphatase (Serum) Maximum Post Baseline Value	4.5000 U/L Standard Deviation 9.19239	85.5000 U/L Standard Deviation 67.17514	14.2500 U/L Standard Deviation 13.08148	104.7143 U/L Standard Deviation 135.05766	49.4000 U/L Standard Deviation 45.70839	78.0000 U/L Standard Deviation 84.43341	95.7500 U/L Standard Deviation 123.57733	72.7143 U/L Standard Deviation 80.35487	138.8571 U/L Standard Deviation 239.39815	27.2222 U/L Standard Deviation 24.80815	294.3333 U/L Standard Deviation 402.47898	47.8571 U/L Standard Deviation 39.29982	19.2500 U/L Standard Deviation 18.85092	34.0000 U/L Standard Deviation 8.48528	49.3333 U/L Standard Deviation 59.21571	39.5556 U/L Standard Deviation 45.42057	24.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 2 Alanine Aminotransferase (Serum) Minimum Post Baseline Value	-6.0000 U/L Standard Deviation 5.65685	-5.0000 U/L Standard Deviation 7.07107	-12.7500 U/L Standard Deviation 8.13173	-1.6429 U/L Standard Deviation 20.22110	-11.6000 U/L Standard Deviation 16.83024	11.26943 U/L Standard Deviation 14.0000	-3.3750 U/L Standard Deviation 11.17315	-3.5714 U/L Standard Deviation 21.62450	-1.5714 U/L Standard Deviation 2.29907	-0.3333 U/L Standard Deviation 9.44722	-22.0000 U/L Standard Deviation 20.07486	-6.1429 U/L Standard Deviation 5.66947	-12.6250 U/L Standard Deviation 15.17458	-8.5000 U/L Standard Deviation 2.12132	-2.8889 U/L Standard Deviation 5.81903	-10.6667 U/L Standard Deviation 13.03840	1.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 2 Alanine Aminotransferase (Serum) Maximum Post Baseline Value	11.5000 U/L Standard Deviation 6.36396	23.5000 U/L Standard Deviation 13.43503	24.2500 U/L Standard Deviation 7.42462	63.7857 U/L Standard Deviation 42.38500	73.8000 U/L Standard Deviation 71.88304	38.0000 U/L Standard Deviation 14.10674	117.7500 U/L Standard Deviation 64.07083	150.1429 U/L Standard Deviation 136.43488	95.1429 U/L Standard Deviation 46.31209	145.8889 U/L Standard Deviation 141.73077	293.0000 U/L Standard Deviation 309.51090	49.7143 U/L Standard Deviation 40.91338	70.0000 U/L Standard Deviation 110.09476	38.0000 U/L Standard Deviation 11.31371	78.4444 U/L Standard Deviation 89.89176	52.8889 U/L Standard Deviation 40.26613	349.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 2 Amylase (Serum) Minimum Post Baseline Value	-8.0000 U/L Standard Deviation 8.48528	60.0000 U/L Standard Deviation 89.09545	-7.0000 U/L Standard Deviation 8.48528	0.8333 U/L Standard Deviation 15.81666	7.6364 U/L Standard Deviation 28.68893	-4.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants	12.0000 U/L Standard Deviation 20.34699	-12.7500 U/L Standard Deviation 19.60230	0.0000 U/L Standard Deviation 23.93045	0.7500 U/L Standard Deviation 14.31491	-13.3333 U/L Standard Deviation 28.36077	20.1667 U/L Standard Deviation 26.11832	-4.0000 U/L Standard Deviation 3.00000	-4.0000 U/L Standard Deviation 8.48528	19.6667 U/L Standard Deviation 46.16348	-18.8000 U/L Standard Deviation 25.50882	13.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 2 Amylase (Serum) Maximum Post Baseline Value	2.5000 U/L Standard Deviation 3.53553	207.0000 U/L Standard Deviation 282.84271	1.5000 U/L Standard Deviation 3.53553	1.8333 U/L Standard Deviation 15.71517	14.4545 U/L Standard Deviation 27.40206	21.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants	12.1667 U/L Standard Deviation 20.28218	17.0000 U/L Standard Deviation 18.67262	8.5000 U/L Standard Deviation 21.56386	4.5000 U/L Standard Deviation 10.84743	2.6667 U/L Standard Deviation 45.08141	22.0000 U/L Standard Deviation 24.23221	-4.0000 U/L Standard Deviation 3.00000	8.0000 U/L Standard Deviation 7.07107	20.0000 U/L Standard Deviation 46.32926	-11.6000 U/L Standard Deviation 27.71823	17.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 2 Aspartate Aminotransferase (Serum) Minimum Post Baseline Value	-4.5000 U/L Standard Deviation 0.70711	-1.5000 U/L Standard Deviation 2.12132	-9.7500 U/L Standard Deviation 2.47487	-1.8571 U/L Standard Deviation 4.63424	-7.8667 U/L Standard Deviation 10.94706	-23.3333 U/L Standard Deviation 14.57166	-9.8750 U/L Standard Deviation 13.37842	-10.2857 U/L Standard Deviation 12.41926	-4.2857 U/L Standard Deviation 6.23737	-1.6667 U/L Standard Deviation 6.80074	-7.6667 U/L Standard Deviation 7.09460	-8.1429 U/L Standard Deviation 9.09997	-8.9 U/L Standard Deviation 7.26	-7.5 U/L Standard Deviation 0.71	-3.6667 U/L Standard Deviation 5.02494	-4.6667 U/L Standard Deviation 5.70088	-8.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 2 Aspartate Aminotransferase (Serum) Maximum Post Baseline Value	7.5000 U/L Standard Deviation 2.12132	17.5000 U/L Standard Deviation 3.53553	16.2500 U/L Standard Deviation 6.01041	84.1429 U/L Standard Deviation 82.69105	143.3333 U/L Standard Deviation 353.35629	55.3333 U/L Standard Deviation 10.96966	95.7500 U/L Standard Deviation 105.06019	151.2857 U/L Standard Deviation 282.47992	72.5714 U/L Standard Deviation 57.86149	74.1111 U/L Standard Deviation 71.85479	280.3333 U/L Standard Deviation 324.62491	32.8571 U/L Standard Deviation 36.56241	81.5 U/L Standard Deviation 171.64	25.0 U/L Standard Deviation 2.83	63.2222 U/L Standard Deviation 92.19650	30.0000 U/L Standard Deviation 23.53189	299.0000 U/L Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from baseline for chemistry laboratory parameters. Baseline = last value before start of treatment

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Bicarbonate (Serum) Minimum Post Baseline Value	0.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	—	—	-8.5000 mmol/L Standard Deviation 1.29099	-7.5143 mmol/L Standard Deviation 3.49401	-3.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	-4.0250 mmol/L Standard Deviation 2.30416	-5.0333 mmol/L Standard Deviation 1.00167	-11.8675 mmol/L Standard Deviation 9.78371	-7.4500 mmol/L Standard Deviation 3.97492	-4.1000 mmol/L Standard Deviation 1.90526	-5.8750 mmol/L Standard Deviation 2.32289	-3.87 mmol/L Standard Deviation 3.308	—	-3.3500 mmol/L Standard Deviation 2.59936	-4.6800 mmol/L Standard Deviation 1.73551	—
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Bicarbonate (Serum) Maximum Post Baseline Value	5.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	—	—	1.0000 mmol/L Standard Deviation 1.41421	2.1857 mmol/L Standard Deviation 2.18893	-2.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	6.8250 mmol/L Standard Deviation 4.57265	2.3000 mmol/L Standard Deviation 1.75784	0.8500 mmol/L Standard Deviation 2.54755	3.1375 mmol/L Standard Deviation 3.55163	2.5667 mmol/L Standard Deviation 3.48473	24.8000 mmol/L Standard Deviation 47.60000	4.98 mmol/L Standard Deviation 3.305	—	3.2500 mmol/L Standard Deviation 2.62996	4.8800 mmol/L Standard Deviation 3.04171	—
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Calcium Corrected (Serum) Minimum Post Baseline Value	-0.1250 mmol/L Standard Deviation 0.02121	-0.1350 mmol/L Standard Deviation 0.01414	-0.2350 mmol/L Standard Deviation 0.14849	-0.4614 mmol/L Standard Deviation 0.18940	-0.4643 mmol/L Standard Deviation 0.19304	-0.4750 mmol/L Standard Deviation 0.30311	-0.6106 mmol/L Standard Deviation 0.29461	-0.5136 mmol/L Standard Deviation 0.13300	-0.6050 mmol/L Standard Deviation 0.22163	-0.4367 mmol/L Standard Deviation 0.10256	-0.5350 mmol/L Standard Deviation 0.11034	-0.4500 mmol/L Standard Deviation 0.22224	-0.4425 mmol/L Standard Deviation 0.14071	-0.6450 mmol/L Standard Deviation 0.13435	-0.4800 mmol/L Standard Deviation 0.12119	-0.4240 mmol/L Standard Deviation 0.14415	—
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Calcium Corrected (Serum) Maximum Post Baseline Value	0.1550 mmol/L Standard Deviation 0.00707	0.1475 mmol/L Standard Deviation 0.10253	0.2025 mmol/L Standard Deviation 0.21567	0.1064 mmol/L Standard Deviation 0.20428	0.1757 mmol/L Standard Deviation 0.11539	0.0917 mmol/L Standard Deviation 0.14216	0.1431 mmol/L Standard Deviation 0.16641	0.1157 mmol/L Standard Deviation 0.13148	0.2175 mmol/L Standard Deviation 0.07777	0.1417 mmol/L Standard Deviation 0.20335	-0.0283 mmol/L Standard Deviation 0.11361	0.0957 mmol/L Standard Deviation 0.11002	0.1063 mmol/L Standard Deviation 0.10374	0.0300 mmol/L Standard Deviation 0.19799	0.0740 mmol/L Standard Deviation 0.09397	0.1630 mmol/L Standard Deviation 0.06676	—
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Calcium, Ionized (Blood) (mmol/L) Minimum Post Baseline Value	0.0225 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	—	-0.2225 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	-0.2033 mmol/L Standard Deviation 0.05774	-0.1558 mmol/L Standard Deviation 0.27691	-0.3700 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	-0.2220 mmol/L Standard Deviation 0.08831	-0.3242 mmol/L Standard Deviation 0.33363	-0.3950 mmol/L Standard Deviation 0.23569	-0.2364 mmol/L Standard Deviation 0.10346	—	-0.2696 mmol/L Standard Deviation 0.12539	-0.1971 mmol/L Standard Deviation 0.05376	-0.5275 mmol/L Standard Deviation 0.20506	-0.1815 mmol/L Standard Deviation 0.10910	-0.0820 mmol/L Standard Deviation 0.67998	-0.0925 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Calcium, Ionized (Blood) (mmol/L) Maximum Post Baseline Value	0.0225 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	—	0.0150 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	-0.0350 mmol/L Standard Deviation 0.09124	0.3386 mmol/L Standard Deviation 0.42193	-0.0200 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	0.2740 mmol/L Standard Deviation 0.44510	-0.0138 mmol/L Standard Deviation 0.10585	17.3332 mmol/L Standard Deviation 45.22988	0.0592 mmol/L Standard Deviation 0.09937	—	0.0989 mmol/L Standard Deviation 0.11111	0.0643 mmol/L Standard Deviation 0.08204	-0.0438 mmol/L Standard Deviation 0.10076	0.0575 mmol/L Standard Deviation 0.13083	0.5025 mmol/L Standard Deviation 0.62937	0.0725 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Chloride (Serum) Minimum Post Baseline Value	-4.5000 mmol/L Standard Deviation 0.70711	-9.5000 mmol/L Standard Deviation 4.94975	-5.0000 mmol/L Standard Deviation 1.41421	-4.4286 mmol/L Standard Deviation 2.37045	-10.1333 mmol/L Standard Deviation 24.80169	-5.0000 mmol/L Standard Deviation 5.29150	-7.3750 mmol/L Standard Deviation 4.77905	-5.5714 mmol/L Standard Deviation 2.93582	-15.4286 mmol/L Standard Deviation 29.94916	-5.1111 mmol/L Standard Deviation 3.48010	-3.0000 mmol/L Standard Deviation 1.00000	-5.4286 mmol/L Standard Deviation 2.82000	-3.1250 mmol/L Standard Deviation 4.58063	-4.5000 mmol/L Standard Deviation 0.70711	-4.1889 mmol/L Standard Deviation 3.81394	-14.4444 mmol/L Standard Deviation 21.11345	-8.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Chloride (Serum) Maximum Post Baseline Value	3.5000 mmol/L Standard Deviation 0.70711	0.5000 mmol/L Standard Deviation 3.53553	6.5000 mmol/L Standard Deviation 3.53553	5.0000 mmol/L Standard Deviation 3.36650	9.4000 mmol/L Standard Deviation 8.64209	11.6667 mmol/L Standard Deviation 3.05505	5.0000 mmol/L Standard Deviation 2.56348	5.4286 mmol/L Standard Deviation 3.40867	10.7143 mmol/L Standard Deviation 7.99405	5.1111 mmol/L Standard Deviation 3.10018	4.3333 mmol/L Standard Deviation 1.15470	5.4286 mmol/L Standard Deviation 4.57738	6.0000 mmol/L Standard Deviation 5.58058	6.0000 mmol/L Standard Deviation 2.82843	3.6333 mmol/L Standard Deviation 3.39264	6.0000 mmol/L Standard Deviation 8.06226	0.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Carbon Dioxide (Plasma) Minimum Post Baseline Value	-6.00 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	-3.00 mmol/L Standard Deviation 0.000	-4.00 mmol/L Standard Deviation 4.243	-7.83 mmol/L Standard Deviation 5.393	-6.15 mmol/L Standard Deviation 2.716	-7.33 mmol/L Standard Deviation 2.082	-8.92 mmol/L Standard Deviation 5.788	-13.12 mmol/L Standard Deviation 7.367	-10.18 mmol/L Standard Deviation 4.032	-9.59 mmol/L Standard Deviation 4.171	-3.00 mmol/L Standard Deviation 2.404	-7.67 mmol/L Standard Deviation 1.528	-5.5600 mmol/L Standard Deviation 6.65004	-8.0000 mmol/L Standard Deviation 4.24264	-5.2333 mmol/L Standard Deviation 4.26224	-5.5000 mmol/L Standard Deviation 2.38048	-9.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Carbon Dioxide (Plasma) Maximum Post Baseline Value	5.00 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants	4.00 mmol/L Standard Deviation 0.000	7.00 mmol/L Standard Deviation 2.828	5.50 mmol/L Standard Deviation 7.089	7.02 mmol/L Standard Deviation 8.784	2.67 mmol/L Standard Deviation 2.082	4.88 mmol/L Standard Deviation 5.841	2.06 mmol/L Standard Deviation 3.531	1.25 mmol/L Standard Deviation 3.304	3.93 mmol/L Standard Deviation 3.622	25.20 mmol/L Standard Deviation 5.374	0.67 mmol/L Standard Deviation 2.082	3.5200 mmol/L Standard Deviation 4.35282	2.5000 mmol/L Standard Deviation 3.53553	1.7500 mmol/L Standard Deviation 1.99374	3.0000 mmol/L Standard Deviation 2.58199	1.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Glucose (Serum Fasting) Minimum Post Baseline Value	-0.7333 mmol/L Standard Deviation 0.80151	-1.7205 mmol/L Standard Deviation 0.78489	-2.1229 mmol/L Standard Deviation 0.80451	-1.7822 mmol/L Standard Deviation 1.22271	-1.9303 mmol/L Standard Deviation 1.73875	-2.0165 mmol/L Standard Deviation 1.28292	-1.7267 mmol/L Standard Deviation 1.12065	-1.2917 mmol/L Standard Deviation 2.58471	-0.7142 mmol/L Standard Deviation 1.10594	-0.3899 mmol/L Standard Deviation 1.35398	-0.9662 mmol/L Standard Deviation 0.69337	-1.2026 mmol/L Standard Deviation 1.14734	-2.7784 mmol/L Standard Deviation 3.30908	-1.6650 mmol/L Standard Deviation 2.04071	-2.0524 mmol/L Standard Deviation 1.98069	-3.8089 mmol/L Standard Deviation 4.81888	-0.7770 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Glucose (Serum Fasting) Maximum Post Baseline Value	2.6098 mmol/L Standard Deviation 0.15521	2.4698 mmol/L Standard Deviation 2.62938	5.8136 mmol/L Standard Deviation 2.02109	2.4246 mmol/L Standard Deviation 2.08954	3.0881 mmol/L Standard Deviation 2.37534	5.9755 mmol/L Standard Deviation 5.04847	6.6410 mmol/L Standard Deviation 12.50771	6.6956 mmol/L Standard Deviation 4.61321	4.2604 mmol/L Standard Deviation 3.84923	4.0611 mmol/L Standard Deviation 2.96891	3.3685 mmol/L Standard Deviation 1.95592	5.6909 mmol/L Standard Deviation 4.20310	4.5039 mmol/L Standard Deviation 5.49686	5.49686 mmol/L Standard Deviation 2.27618	2.5520 mmol/L Standard Deviation 3.08923	3.0482 mmol/L Standard Deviation 7.55874	3.4410 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Potassium (Serum) Minimum Post Baseline Value	-0.5500 mmol/L Standard Deviation 0.07071	-0.6500 mmol/L Standard Deviation 0.63640	-0.6750 mmol/L Standard Deviation 0.53033	-0.9457 mmol/L Standard Deviation 0.75540	-0.7000 mmol/L Standard Deviation 0.56821	-0.6667 mmol/L Standard Deviation 0.40415	-0.8750 mmol/L Standard Deviation 0.58737	-0.8214 mmol/L Standard Deviation 0.34139	-1.0571 mmol/L Standard Deviation 0.29921	-0.8667 mmol/L Standard Deviation 0.53852	-1.1000 mmol/L Standard Deviation 0.36056	-0.7857 mmol/L Standard Deviation 0.29681	-0.6875 mmol/L Standard Deviation 0.58661	-0.7500 mmol/L Standard Deviation 0.35355	-0.5000 mmol/L Standard Deviation 0.30000	-0.7778 mmol/L Standard Deviation 0.40242	-0.7000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Potassium (Serum) Maximum Post Baseline Value	0.5000 mmol/L Standard Deviation 0.28284	0.5000 mmol/L Standard Deviation 0.28284	0.2250 mmol/L Standard Deviation 0.17678	0.7286 mmol/L Standard Deviation 0.47859	0.5400 mmol/L Standard Deviation 0.35416	0.7000 mmol/L Standard Deviation 0.98489	0.4625 mmol/L Standard Deviation 0.27223	0.6071 mmol/L Standard Deviation 0.32968	0.5857 mmol/L Standard Deviation 0.55806	0.3111 mmol/L Standard Deviation 0.32189	0.4000 mmol/L Standard Deviation 0.43589	0.7286 mmol/L Standard Deviation 0.85579	0.7125 mmol/L Standard Deviation 0.44219	0.5500 mmol/L Standard Deviation 0.49497	0.4933 mmol/L Standard Deviation 0.52192	15.2000 mmol/L Standard Deviation 44.25113	0.2000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Magnesium (Serum) Minimum Post Baseline Value	-0.1678 mmol/L Standard Deviation 0.05339	-0.0822 mmol/L Standard Deviation 0.11625	-0.1747 mmol/L Standard Deviation 0.04359	-0.1325 mmol/L Standard Deviation 0.09877	-0.1434 mmol/L Standard Deviation 0.15976	-0.0685 mmol/L Standard Deviation 0.06278	-0.1816 mmol/L Standard Deviation 0.11047	-0.1621 mmol/L Standard Deviation 0.12041	-0.1554 mmol/L Standard Deviation 0.13947	-0.1364 mmol/L Standard Deviation 0.11191	-0.1742 mmol/L Standard Deviation 0.11591	-0.1289 mmol/L Standard Deviation 0.12833	-0.0969 mmol/L Standard Deviation 0.07597	-0.0822 mmol/L Standard Deviation 0.05812	-0.0995 mmol/L Standard Deviation 0.07483	-0.0616 mmol/L Standard Deviation 0.06859	-0.1233 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Magnesium (Serum) Maximum Post Baseline Value	0.0661 mmol/L Standard Deviation 0.02277	0.2466 mmol/L Standard Deviation 0.29062	0.0514 mmol/L Standard Deviation 0.07266	0.3527 mmol/L Standard Deviation 0.17041	0.2818 mmol/L Standard Deviation 0.14292	0.2466 mmol/L Standard Deviation 0.12330	0.1397 mmol/L Standard Deviation 0.15729	0.2115 mmol/L Standard Deviation 0.17599	0.2198 mmol/L Standard Deviation 0.21791	0.2259 mmol/L Standard Deviation 0.11524	0.1604 mmol/L Standard Deviation 0.12659	0.5257 mmol/L Standard Deviation 0.79291	0.2620 mmol/L Standard Deviation 0.24586	0.7213 mmol/L Standard Deviation 0.26447	0.2454 mmol/L Standard Deviation 0.16916	0.2256 mmol/L Standard Deviation 0.12779	0.1644 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Phosphate (Serum) Minimum Post Baseline Value	-0.4757 mmol/L Standard Deviation 0.14948	-0.0485 mmol/L Standard Deviation 0.06852	-0.3069 mmol/L Standard Deviation 0.06852	-0.6302 mmol/L Standard Deviation 0.26517	-0.5801 mmol/L Standard Deviation 0.28215	-0.7752 mmol/L Standard Deviation 0.43455	-0.6085 mmol/L Standard Deviation 0.28717	-0.5723 mmol/L Standard Deviation 0.25444	-0.4597 mmol/L Standard Deviation 0.38489	-0.6305 mmol/L Standard Deviation 0.25010	-1.0614 mmol/L Standard Deviation 0.37317	-0.7058 mmol/L Standard Deviation 0.31457	-0.4598 mmol/L Standard Deviation 0.50333	-0.5168 mmol/L Standard Deviation 0.31975	-0.4614 mmol/L Standard Deviation 0.29484	-0.2159 mmol/L Standard Deviation 0.25466	-0.3553 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Phosphate (Serum) Maximum Post Baseline Value	0.1396 mmol/L Standard Deviation 0.01471	0.3715 mmol/L Standard Deviation 0.11420	0.4684 mmol/L Standard Deviation 0.38827	0.7003 mmol/L Standard Deviation 0.49600	0.7392 mmol/L Standard Deviation 0.61769	0.5276 mmol/L Standard Deviation 0.57448	0.6354 mmol/L Standard Deviation 0.51976	1.1399 mmol/L Standard Deviation 0.73804	0.8597 mmol/L Standard Deviation 0.91607	0.3119 mmol/L Standard Deviation 0.55165	0.0392 mmol/L Standard Deviation 0.12539	0.6580 mmol/L Standard Deviation 0.48893	0.8600 mmol/L Standard Deviation 0.82275	0.4684 mmol/L Standard Deviation 0.29691	0.6059 mmol/L Standard Deviation 0.33589	0.4636 mmol/L Standard Deviation 0.35631	0.0646 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Sodium (Serum) Minimum Post Baseline Value	-7.0000 mmol/L Standard Deviation 2.82843	-4.0000 mmol/L Standard Deviation 1.41421	-7.5000 mmol/L Standard Deviation 4.94975	-5.4286 mmol/L Standard Deviation 2.50713	-7.1333 mmol/L Standard Deviation 7.98093	-4.0000 mmol/L Standard Deviation 3.60555	-6.1250 mmol/L Standard Deviation 2.53194	-6.4286 mmol/L Standard Deviation 2.22539	-5.0000 mmol/L Standard Deviation 1.15470	-6.8889 mmol/L Standard Deviation 2.84800	-7.0000 mmol/L Standard Deviation 1.00000	-5.5714 mmol/L Standard Deviation 2.69921	-2.6250 mmol/L Standard Deviation 3.42000	-8.5000 mmol/L Standard Deviation 2.12132	-4.4111 mmol/L Standard Deviation 2.97844	-5.2222 mmol/L Standard Deviation 3.49205	-12.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Sodium (Serum) Maximum Post Baseline Value	1.0000 mmol/L Standard Deviation 0.00000	2.5000 mmol/L Standard Deviation 2.12132	3.5000 mmol/L Standard Deviation 0.70711	2.7143 mmol/L Standard Deviation 3.25137	4.6667 mmol/L Standard Deviation 4.13464	5.3333 mmol/L Standard Deviation 6.50641	3.3750 mmol/L Standard Deviation 5.65528	2.4286 mmol/L Standard Deviation 3.10146	5.7143 mmol/L Standard Deviation 6.04743	1.6667 mmol/L Standard Deviation 1.58114	1.6667 mmol/L Standard Deviation 2.08167	2.5714 mmol/L Standard Deviation 0.97590	4.5000 mmol/L Standard Deviation 4.47214	0.0000 mmol/L Standard Deviation 1.41421	2.6778 mmol/L Standard Deviation 2.53662	3.8889 mmol/L Standard Deviation 2.66667	-1.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Blood Urea Nitrogen (Serum) Minimum Post Baseline Value	-2.1640 mmol/L Standard Deviation 1.04086	-0.8925 mmol/L Standard Deviation 1.76706	-2.1420 mmol/L Standard Deviation 1.51462	-1.9180 mmol/L Standard Deviation 1.23345	-1.4420 mmol/L Standard Deviation 1.63613	-1.7850 mmol/L Standard Deviation 0.94453	-1.6767 mmol/L Standard Deviation 1.92439	-1.3615 mmol/L Standard Deviation 1.87780	-1.3589 mmol/L Standard Deviation 1.65079	-1.1995 mmol/L Standard Deviation 2.01204	-1.8114 mmol/L Standard Deviation 0.77173	-0.8080 mmol/L Standard Deviation 1.44364	-0.2616 mmol/L Standard Deviation 1.46975	-3.7485 mmol/L Standard Deviation 1.26219	-1.4423 mmol/L Standard Deviation 2.08076	-0.9405 mmol/L Standard Deviation 1.10505	0.0000 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline by Laboratory Test - Chemistry Parameters 3 Blood Urea Nitrogen (Serum) Maximum Post Baseline Value	2.4780 mmol/L Standard Deviation 0.53457	4.9980 mmol/L Standard Deviation 2.01950	5.1765 mmol/L Standard Deviation 0.75731	6.8120 mmol/L Standard Deviation 6.77422	8.3157 mmol/L Standard Deviation 4.35216	9.5200 mmol/L Standard Deviation 8.51827	9.7553 mmol/L Standard Deviation 5.39524	13.6523 mmol/L Standard Deviation 8.34637	14.8533 mmol/L Standard Deviation 9.94930	11.0090 mmol/L Standard Deviation 3.89546	10.5890 mmol/L Standard Deviation 13.37754	10.5656 mmol/L Standard Deviation 5.62941	10.1050 mmol/L Standard Deviation 7.49087	11.4240 mmol/L Standard Deviation 0.50487	7.6687 mmol/L Standard Deviation 2.92428	8.1828 mmol/L Standard Deviation 4.82377	8.5680 mmol/L Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline for Vital Signs by Test - Parameters 1 Systolic Blood Pressure Minimum Post Baseline Value	-18.5 mmHg Standard Deviation 3.54	-15.0 mmHg Standard Deviation 2.83	-19.5 mmHg Standard Deviation 13.44	-37.0 mmHg Standard Deviation 16.73	-27.9 mmHg Standard Deviation 14.65	-54.0 mmHg Standard Deviation 16.64	-27.8 mmHg Standard Deviation 13.58	-35.1 mmHg Standard Deviation 16.20	-29.1 mmHg Standard Deviation 10.46	-23.0 mmHg Standard Deviation 12.27	-36.7 mmHg Standard Deviation 23.07	-17.1 mmHg Standard Deviation 10.90	-22.8 mmHg Standard Deviation 12.79	-10.0 mmHg Standard Deviation 11.31	-27.3 mmHg Standard Deviation 16.65	-29.1 mmHg Standard Deviation 18.20	-31.0 mmHg Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Vital Signs by Test - Parameters 1 Systolic Blood Pressure Maximum Post Baseline Value	23.0 mmHg Standard Deviation 0.00	33.0 mmHg Standard Deviation 0.00	18.5 mmHg Standard Deviation 7.78	18.6 mmHg Standard Deviation 20.86	22.1 mmHg Standard Deviation 13.36	9.3 mmHg Standard Deviation 7.77	29.5 mmHg Standard Deviation 16.25	26.1 mmHg Standard Deviation 10.57	25.4 mmHg Standard Deviation 11.25	30.8 mmHg Standard Deviation 18.08	20.0 mmHg Standard Deviation 8.54	29.0 mmHg Standard Deviation 8.33	25.3 mmHg Standard Deviation 12.68	45.5 mmHg Standard Deviation 23.33	24.4 mmHg Standard Deviation 9.50	27.3 mmHg Standard Deviation 21.51	26.0 mmHg Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Vital Signs by Test - Parameters 1 Diastolic Blood Pressure Minimum Post Baseline Value	-7.0 mmHg Standard Deviation 7.07	-2.0 mmHg Standard Deviation 7.07	-18.0 mmHg Standard Deviation 19.80	-16.7 mmHg Standard Deviation 6.65	-16.8 mmHg Standard Deviation 7.18	-22.7 mmHg Standard Deviation 9.87	-17.8 mmHg Standard Deviation 6.36	-17.3 mmHg Standard Deviation 8.44	-19.1 mmHg Standard Deviation 8.43	-15.0 mmHg Standard Deviation 12.87	-25.7 mmHg Standard Deviation 11.55	-14.9 mmHg Standard Deviation 10.79	-16.6 mmHg Standard Deviation 11.90	-13.0 mmHg Standard Deviation 14.14	-17.2 mmHg Standard Deviation 7.60	-19.1 mmHg Standard Deviation 11.47	-10.0 mmHg Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Vital Signs by Test - Parameters 1 Diastolic Blood Pressure Maximum Post Baseline Value	23.0 mmHg Standard Deviation 0.00	33.0 mmHg Standard Deviation 4.24	12.5 mmHg Standard Deviation 6.36	16.6 mmHg Standard Deviation 1.90	17.4 mmHg Standard Deviation 13.29	10.3 mmHg Standard Deviation 2.08	22.6 mmHg Standard Deviation 9.96	17.7 mmHg Standard Deviation 8.26	18.3 mmHg Standard Deviation 9.43	23.6 mmHg Standard Deviation 9.70	15.0 mmHg Standard Deviation 3.46	19.4 mmHg Standard Deviation 13.72	17.9 mmHg Standard Deviation 8.37	20.0 mmHg Standard Deviation 9.90	16.9 mmHg Standard Deviation 11.54	14.3 mmHg Standard Deviation 16.01	26.0 mmHg Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline for Vital Signs by Test - Parameters 2 Pulse Minimum Post Baseline Value	-15.5 beats/min Standard Deviation 4.95	-6.0 beats/min Standard Deviation 5.66	-21.5 beats/min Standard Deviation 10.61	-9.7 beats/min Standard Deviation 13.41	-14.1 beats/min Standard Deviation 10.85	-23.0 beats/min Standard Deviation 12.12	-14.0 beats/min Standard Deviation 8.47	-14.7 beats/min Standard Deviation 10.34	-25.1 beats/min Standard Deviation 14.10	-18.4 beats/min Standard Deviation 10.43	-22.7 beats/min Standard Deviation 9.50	-24.7 beats/min Standard Deviation 19.90	-15.6 beats/min Standard Deviation 9.59	-11.0 beats/min Standard Deviation 8.49	-21.9 beats/min Standard Deviation 8.10	-11.8 beats/min Standard Deviation 9.58	-20.0 beats/min Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Vital Signs by Test - Parameters 2 Pulse Maximum Post Baseline Value	29.0 beats/min Standard Deviation 9.90	28.0 beats/min Standard Deviation 8.49	17.0 beats/min Standard Deviation 18.38	27.7 beats/min Standard Deviation 24.98	32.0 beats/min Standard Deviation 12.10	14.0 beats/min Standard Deviation 18.25	38.9 beats/min Standard Deviation 16.86	23.9 beats/min Standard Deviation 12.33	30.6 beats/min Standard Deviation 16.53	26.3 beats/min Standard Deviation 22.84	28.0 beats/min Standard Deviation 19.00	22.1 beats/min Standard Deviation 10.99	29.4 beats/min Standard Deviation 12.69	43.5 beats/min Standard Deviation 13.44	21.7 beats/min Standard Deviation 21.82	25.3 beats/min Standard Deviation 14.93	32.0 beats/min Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Vital Signs by Test - Parameters 2 Respiration Minimum Post Baseline Value	-1.0 beats/min Standard Deviation 1.41	-3.0 beats/min Standard Deviation 1.41	-2.0 beats/min Standard Deviation 0.00	-1.0 beats/min Standard Deviation 1.73	-1.9 beats/min Standard Deviation 1.39	-2.3 beats/min Standard Deviation 2.52	-2.4 beats/min Standard Deviation 2.97	-2.4 beats/min Standard Deviation 2.57	-4.9 beats/min Standard Deviation 1.95	-1.1 beats/min Standard Deviation 1.36	-1.7 beats/min Standard Deviation 2.08	-2.9 beats/min Standard Deviation 2.79	-2.8 beats/min Standard Deviation 3.41	-3.5 beats/min Standard Deviation 2.12	-2.4 beats/min Standard Deviation 1.59	-3.3 beats/min Standard Deviation 2.65	-2.0 beats/min Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Vital Signs by Test - Parameters 2 Respiration Maximum Post Baseline Value	2.0 beats/min Standard Deviation 2.83	3.0 beats/min Standard Deviation 3.0	4.0 beats/min Standard Deviation 2.83	2.9 beats/min Standard Deviation 1.68	5.0 beats/min Standard Deviation 5.15	4.0 beats/min Standard Deviation 2.00	3.9 beats/min Standard Deviation 2.64	4.7 beats/min Standard Deviation 3.82	2.9 beats/min Standard Deviation 1.07	3.4 beats/min Standard Deviation 3.36	3.7 beats/min Standard Deviation 0.58	5.3 beats/min Standard Deviation 4.11	3.3 beats/min Standard Deviation 3.58	2.0 beats/min Standard Deviation 0.00	3.9 beats/min Standard Deviation 6.95	1.6 beats/min Standard Deviation 1.42	2.0 beats/min Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline for Vital Signs by Test - Parameters 3 Temperature Minimum Post Baseline Value	-0.15 Celsius Standard Deviation 0.354	-0.45 Celsius Standard Deviation 0.212	-0.25 Celsius Standard Deviation 0.354	-0.50 Celsius Standard Deviation 0.392	-0.77 Celsius Standard Deviation 0.443	-1.47 Celsius Standard Deviation 1.686	-0.61 Celsius Standard Deviation 0.340	-0.76 Celsius Standard Deviation 0.395	-1.69 Celsius Standard Deviation 0.830	-1.08 Celsius Standard Deviation 0.499	-0.50 Celsius Standard Deviation 0.300	-1.16 Celsius Standard Deviation 0.678	-0.99 Celsius Standard Deviation 0.511	-0.55 Celsius Standard Deviation 0.354	-0.74 Celsius Standard Deviation 0.456	-3.31 Celsius Standard Deviation 6.473	-0.60 Celsius Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Vital Signs by Test - Parameters 3 Temperature Maximum Post Baseline Value	0.65 Celsius Standard Deviation 0.778	0.65 Celsius Standard Deviation 0.212	0.80 Celsius Standard Deviation 0.566	0.77 Celsius Standard Deviation 0.591	0.93 Celsius Standard Deviation 0.704	-0.03 Celsius Standard Deviation 0.513	0.86 Celsius Standard Deviation 0.657	1.67 Celsius Standard Deviation 1.378	0.73 Celsius Standard Deviation 0.647	0.39 Celsius Standard Deviation 0.326	1.40 Celsius Standard Deviation 0.866	0.67 Celsius Standard Deviation 0.468	0.73 Celsius Standard Deviation 0.865	0.25 Celsius Standard Deviation 0.071	0.49 Celsius Standard Deviation 0.607	6.97 Celsius Standard Deviation 19.185	0.90 Celsius Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from Baseline for Vital Signs Parameters. Baseline = last value before start of treatment.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=7 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=8 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline for Vital Signs by Test - Parameters 4 Weight Maximum Post Baseline Value	4.00 Kg Standard Deviation 2.404	0.70 Kg Standard Deviation 0.424	2.10 Kg Standard Deviation 0.707	3.40 Kg Standard Deviation 4.987	2.19 Kg Standard Deviation 4.788	2.83 Kg Standard Deviation 3.539	2.55 Kg Standard Deviation 3.789	2.13 Kg Standard Deviation 2.833	3.89 Kg Standard Deviation 3.074	0.54 Kg Standard Deviation 1.415	1.70 Kg Standard Deviation 1.947	0.94 Kg Standard Deviation 2.028	1.27 Kg Standard Deviation 3.364	0.55 Kg Standard Deviation 0.778	0.89 Kg Standard Deviation 2.194	1.74 Kg Standard Deviation 3.250	4.60 Kg Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Vital Signs by Test - Parameters 4 Weight Minimum Post Baseline Value	-1.20 Kg Standard Deviation 1.697	-2.05 Kg Standard Deviation 0.495	-4.40 Kg Standard Deviation 6.223	-4.27 Kg Standard Deviation 3.410	-4.51 Kg Standard Deviation 2.254	-3.13 Kg Standard Deviation 2.928	-5.38 Kg Standard Deviation 5.135	-2.60 Kg Standard Deviation 3.475	-3.86 Kg Standard Deviation 2.375	-3.40 Kg Standard Deviation 4.310	-3.57 Kg Standard Deviation 1.358	-5.84 Kg Standard Deviation 1.786	-4.37 Kg Standard Deviation 3.617	-8.55 Kg Standard Deviation 5.303	-2.44 Kg Standard Deviation 2.993	-4.84 Kg Standard Deviation 3.910	0.00 Kg Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=8 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=8 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1 ECG Mean Heart Rate Minimum Post Baseline Value	-7.6667 beats/min Standard Deviation 4.24264	-7.3333 beats/min Standard Deviation 3.29983	-9.5000 beats/min Standard Deviation 1.64992	-12.1429 beats/min Standard Deviation 6.43445	-11.0667 beats/min Standard Deviation 6.22106	-14.6667 beats/min Standard Deviation 16.75642	-11.4167 beats/min Standard Deviation 10.22563	-17.6190 beats/min Standard Deviation 12.60280	-19.7619 beats/min Standard Deviation 10.39536	-12.6667 beats/min Standard Deviation 7.66848	-18.6667 beats/min Standard Deviation 5.84047	-14.6190 beats/min Standard Deviation 12.27981	-13.8333 beats/min Standard Deviation 12.14463	-3.5000 beats/min Standard Deviation 8.24958	-13.1250 beats/min Standard Deviation 11.77560	-15.8750 beats/min Standard Deviation 7.08662	-9.0000 beats/min Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 1 ECG Mean Heart Rate Maximum Post Baseline Value	34.3333 beats/min Standard Deviation 19.79899	16.1667 beats/min Standard Deviation 8.72098	12.0000 beats/min Standard Deviation 2.35702	12.1429 beats/min Standard Deviation 5.74088	14.4000 beats/min Standard Deviation 8.57108	7.0000 beats/min Standard Deviation 9.02466	22.3333 beats/min Standard Deviation 13.38324	9.0952 beats/min Standard Deviation 9.70627	16.3810 beats/min Standard Deviation 9.12349	15.2222 beats/min Standard Deviation 14.31491	10.0000 beats/min Standard Deviation 12.81059	24.2381 beats/min Standard Deviation 14.62331	12.9167 beats/min Standard Deviation 8.59633	14.5000 beats/min Standard Deviation 5.42115	7.5000 beats/min Standard Deviation 7.95024	4.8750 beats/min Standard Deviation 5.46253	22.0000 beats/min Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Change from Baseline for Electrocardiogram (ECG) Parameters. Baseline = last value before start of treatment.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=8 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=8 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 RR Interval, Aggregate Minimum Post Baseline Value	-227.8333 msec Standard Deviation 115.25841	-154.1667 msec Standard Deviation 60.10408	-100.0000 msec Standard Deviation 40.54079	-88.3810 msec Standard Deviation 43.76047	-120.3111 msec Standard Deviation 73.42359	-90.3333 msec Standard Deviation 130.08203	-214.3333 msec Standard Deviation 104.85455	-87.4286 msec Standard Deviation 76.34879	-120.5714 msec Standard Deviation 75.49263	-124.4815 msec Standard Deviation 110.59047	-56.2222 msec Standard Deviation 66.17513	-172.6667 msec Standard Deviation 101.57519	-95.5833 msec Standard Deviation 71.55434	-204.1667 msec Standard Deviation 102.53048	-62.1667 msec Standard Deviation 91.12036	-49.6250 msec Standard Deviation 54.53539	-179.6667 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 RR Interval, Aggregate Maximum Post Baseline Value	79.1667 msec Standard Deviation 37.47666	95.8333 msec Standard Deviation 33.23402	101.5000 msec Standard Deviation 11.07801	126.6190 msec Standard Deviation 77.45092	130.0889 msec Standard Deviation 103.01028	122.0000 msec Standard Deviation 189.59694	155.9167 msec Standard Deviation 134.00577	214.8571 msec Standard Deviation 139.93727	245.8571 msec Standard Deviation 205.30329	168.4074 msec Standard Deviation 120.28609	189.7778 msec Standard Deviation 60.61750	168.7619 msec Standard Deviation 147.66074	151.7917 msec Standard Deviation 121.02039	59.3333 msec Standard Deviation 144.24978	136.5833 msec Standard Deviation 98.81002	193.0000 msec Standard Deviation 72.50638	110.3333 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 PR Interval, Aggregate Minimum Post Baseline Value	-10.6667 msec Standard Deviation 0.94281	-17.6667 msec Standard Deviation 2.82843	-13.1667 msec Standard Deviation 3.06413	-18.3333 msec Standard Deviation 9.18453	-33.0222 msec Standard Deviation 30.52672	-12.2222 msec Standard Deviation 6.16742	-17.7619 msec Standard Deviation 10.10815	-22.1111 msec Standard Deviation 9.44144	-14.9524 msec Standard Deviation 14.86785	-26.2593 msec Standard Deviation 13.96004	-8.5556 msec Standard Deviation 7.01057	-19.5000 msec Standard Deviation 15.86576	-24.2917 msec Standard Deviation 13.70950	-25.0000 msec Standard Deviation 22.62742	-22.0000 msec Standard Deviation 5.94045	-21.2917 msec Standard Deviation 15.15050	-16.0000 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 PR Interval, Aggregate Maximum Post Baseline Value	17.3333 msec Standard Deviation 0.47140	11.3333 msec Standard Deviation 1.41421	25.3333 msec Standard Deviation 14.61354	21.1667 msec Standard Deviation 16.32142	11.8444 msec Standard Deviation 9.61387	13.1111 msec Standard Deviation 3.35548	21.0952 msec Standard Deviation 14.84203	20.8889 msec Standard Deviation 18.09809	23.0476 msec Standard Deviation 21.51866	8.7407 msec Standard Deviation 8.21884	21.1111 msec Standard Deviation 4.53791	18.0000 msec Standard Deviation 17.54106	21.8333 msec Standard Deviation 17.58697	13.5000 msec Standard Deviation 4.94975	7.6667 msec Standard Deviation 11.36466	17.9583 msec Standard Deviation 12.78446	11.0000 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 QRS Duration, Aggregate Minimum Post Baseline Value	-11.1667 msec Standard Deviation 4.94975	-3.6667 msec Standard Deviation 5.65685	-18.1667 msec Standard Deviation 2.59272	-6.9524 msec Standard Deviation 5.68764	-10.3333 msec Standard Deviation 5.60187	-11.4444 msec Standard Deviation 2.14303	-16.9167 msec Standard Deviation 14.64582	-13.1429 msec Standard Deviation 6.33876	-5.9048 msec Standard Deviation 3.62968	-12.5926 msec Standard Deviation 5.66612	-5.8889 msec Standard Deviation 2.69430	-10.5714 msec Standard Deviation 10.26990	-7.3750 msec Standard Deviation 5.51603	-6.6667 msec Standard Deviation 0.00000	-13.7500 msec Standard Deviation 7.04802	-9.8333 msec Standard Deviation 8.09468	-7.0000 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 QRS Duration, Aggregate Maximum Post Baseline Value	15.8333 msec Standard Deviation 2.12132	11.8333 msec Standard Deviation 3.53553	8.3333 msec Standard Deviation 2.35702	11.3333 msec Standard Deviation 6.12826	10.1333 msec Standard Deviation 3.75182	10.8889 msec Standard Deviation 15.25463	9.3333 msec Standard Deviation 8.49089	7.0000 msec Standard Deviation 6.85025	13.5238 msec Standard Deviation 6.72711	7.2963 msec Standard Deviation 4.94819	12.7778 msec Standard Deviation 1.83586	17.2857 msec Standard Deviation 17.24919	11.6250 msec Standard Deviation 7.44170	14.8333 msec Standard Deviation 7.77817	7.8750 msec Standard Deviation 4.57369	12.2917 msec Standard Deviation 5.39676	26.0000 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 QT Interval, Aggregate Minimum Post Baseline Value	-47.3333 msec Standard Deviation 2.82843	-43.1667 msec Standard Deviation 10.13520	-36.0000 msec Standard Deviation 2.35702	-29.1667 msec Standard Deviation 24.44400	-35.9778 msec Standard Deviation 24.63978	-11.6667 msec Standard Deviation 27.42464	-44.8750 msec Standard Deviation 22.71140	-30.0952 msec Standard Deviation 26.46361	-36.4286 msec Standard Deviation 21.44823	-36.8889 msec Standard Deviation 29.53341	-15.7778 msec Standard Deviation 18.67956	-44.7619 msec Standard Deviation 18.83526	-37.4583 msec Standard Deviation 21.83047	-30.0000 msec Standard Deviation 20.27039	-18.2083 msec Standard Deviation 28.82125	-13.3333 msec Standard Deviation 17.30033	-43.0000 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 QT Interval, Aggregate Maximum Post Baseline Value	15.1667 msec Standard Deviation 13.43503	25.8333 msec Standard Deviation 6.83537	31.0000 msec Standard Deviation 27.34146	33.2619 msec Standard Deviation 20.14711	41.2889 msec Standard Deviation 25.74844	31.0000 msec Standard Deviation 33.88379	35.1250 msec Standard Deviation 22.78257	49.4762 msec Standard Deviation 44.13316	70.7143 msec Standard Deviation 52.20559	35.7778 msec Standard Deviation 19.04089	51.2222 msec Standard Deviation 23.57101	40.2381 msec Standard Deviation 24.11985	47.9167 msec Standard Deviation 32.36388	34.5000 msec Standard Deviation 30.87700	49.5417 msec Standard Deviation 26.98144	57.0417 msec Standard Deviation 20.03920	31.0000 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 QTcB Interval, Aggregate Minimum Post Baseline Value	-26.6667 msec Standard Deviation 18.85618	-13.6667 msec Standard Deviation 4.71405	-26.1667 msec Standard Deviation 7.77817	-37.9048 msec Standard Deviation 23.49288	-26.0000 msec Standard Deviation 14.11630	-33.6667 msec Standard Deviation 30.68840	-35.9167 msec Standard Deviation 12.32593	-43.5714 msec Standard Deviation 15.36315	-23.2381 msec Standard Deviation 21.81718	-37.8519 msec Standard Deviation 13.50834	-24.3333 msec Standard Deviation 12.44097	-28.9048 msec Standard Deviation 11.31160	-27.7083 msec Standard Deviation 25.60347	-2.6667 msec Standard Deviation 2.35702	-24.5000 msec Standard Deviation 19.07213	-17.7083 msec Standard Deviation 19.25059	-19.3333 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 QTcB Interval, Aggregate Maximum Post Baseline Value	30.3333 msec Standard Deviation 34.41253	29.3333 msec Standard Deviation 13.67073	27.8333 msec Standard Deviation 20.50610	34.0952 msec Standard Deviation 14.69784	40.2667 msec Standard Deviation 20.09154	40.0000 msec Standard Deviation 14.16961	46.3333 msec Standard Deviation 47.27025	26.5714 msec Standard Deviation 12.68086	35.9048 msec Standard Deviation 22.60999	30.8148 msec Standard Deviation 20.01466	35.6667 msec Standard Deviation 17.63834	28.6667 msec Standard Deviation 14.31394	41.2917 msec Standard Deviation 26.23728	57.8333 msec Standard Deviation 13.90643	41.5000 msec Standard Deviation 23.81343	33.5417 msec Standard Deviation 2.98641	27.6667 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 QTcF Interval, Aggregate Minimum Post Baseline Value	-23.3333 msec Standard Deviation 15.55635	-23.1667 msec Standard Deviation 0.70711	-24.8333 msec Standard Deviation 2.59272	-31.0000 msec Standard Deviation 19.99074	-25.9333 msec Standard Deviation 17.71879	-21.7778 msec Standard Deviation 23.04665	-32.2917 msec Standard Deviation 10.84880	-32.8095 msec Standard Deviation 19.63260	-24.1429 msec Standard Deviation 17.22279	-33.2963 msec Standard Deviation 15.06047	-15.0000 msec Standard Deviation 8.37324	-28.2381 msec Standard Deviation 15.88234	-29.5000 msec Standard Deviation 23.42228	-7.5000 msec Standard Deviation 5.42115	-18.8333 msec Standard Deviation 21.34672	-12.1250 msec Standard Deviation 15.84542	-19.0000 msec Standard Deviation NA SD not calculated due to insufficient number of participants
Change From Baseline for Electrocardiogram (ECG) by Test - Parameters 2 QTcF Interval, Aggregate Maximum Post Baseline Value	23.1667 msec Standard Deviation 24.74874	21.3333 msec Standard Deviation 8.48528	25.1667 msec Standard Deviation 28.51997	30.8571 msec Standard Deviation 15.99983	37.0000 msec Standard Deviation 23.07613	35.5556 msec Standard Deviation 15.84064	35.3333 msec Standard Deviation 29.24120	30.1905 msec Standard Deviation 24.71156	42.7143 msec Standard Deviation 31.84594	27.1481 msec Standard Deviation 13.66780	37.3333 msec Standard Deviation 20.52911	25.3333 msec Standard Deviation 14.23480	42.2500 msec Standard Deviation 23.41872	43.5000 msec Standard Deviation 8.72098	41.4167 msec Standard Deviation 17.87767	36.7500 msec Standard Deviation 6.69932	29.0000 msec Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Number of participants with post-baseline grade increase or decrease from baseline. Grade 0=; Grade 1=; Grade 2=; Grade 3=; Grade 4=; Grade 5=; . Baseline = last value before start of treatment.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Eastern Cooperative Oncology Group (ECOG) Performance Status Post Baseline Grade Increase	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants	2 Participants	3 Participants	1 Participants	2 Participants	0 Participants	2 Participants	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Post Baseline Grade Decrease	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline until 28 days post last dose (Up to 25 months)

Population: All treated participants with baseline and post baseline measurements

Left Ventricular Ejection Fraction (LVEF) percent change from baseline. Baseline = last value before start of treatment.

Minimum Post Baseline Value=lowest value of the measured parameter is recorded after the baseline measurement.

Maximum Post Baseline Value=highest value of the measured parameter is recorded after the baseline measurement.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=1 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=4 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=7 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=1 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=4 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=3 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=5 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=3 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=2 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=4 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=2 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=3 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=3 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline Maximum Post Baseline Value	-8.1 Percent change Standard Deviation 15.88	15.2 Percent change Standard Deviation 0.88	-3.5 Percent change Standard Deviation NA SD not calculated due to insufficient number of participants	-9.1 Percent change Standard Deviation 18.42	1.8 Percent change Standard Deviation 7.37	-1.6 Percent change Standard Deviation NA SD not calculated due to insufficient number of participants	3.2 Percent change Standard Deviation 9.86	-3.7 Percent change Standard Deviation 8.00	1.8 Percent change Standard Deviation 10.63	0.1 Percent change Standard Deviation 17.54	3.1 Percent change Standard Deviation 2.11	8.7 Percent change Standard Deviation 10.19	-8.3 Percent change Standard Deviation 11.79	17.5 Percent change Standard Deviation 26.66	5.2 Percent change Standard Deviation 26.32	-3.3 Percent change Standard Deviation 8.62	1.5 Percent change Standard Deviation NA SD not calculated due to insufficient number of participants
Left Ventricular Ejection Fraction (LVEF) Percent Change From Baseline Minimum Post Baseline Value	-8.1 Percent change Standard Deviation 15.88	15.2 Percent change Standard Deviation 0.88	-3.5 Percent change Standard Deviation NA SD not calculated due to insufficient number of participants	-9.9 Percent change Standard Deviation 17.61	1.8 Percent change Standard Deviation 7.37	-9.8 Percent change Standard Deviation NA SD not calculated due to insufficient number of participants	3.2 Percent change Standard Deviation 9.86	-3.7 Percent change Standard Deviation 8.00	1.8 Percent change Standard Deviation 10.63	0.1 Percent change Standard Deviation 17.54	2.3 Percent change Standard Deviation 3.21	8.7 Percent change Standard Deviation 10.19	-8.3 Percent change Standard Deviation 11.79	17.5 Percent change Standard Deviation 26.66	5.2 Percent change Standard Deviation 26.32	-3.3 Percent change Standard Deviation 8.62	1.0 Percent change Standard Deviation NA SD not calculated due to insufficient number of participants

SECONDARY outcome

Timeframe: Up to approximately 25 months after the last dose

Population: All treated participants

Objectve response is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission [CR] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)) or Morphologic Leukemia - Free State or partial remission. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000/μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Objective Response Rate (ORR)	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	6.7 Percent of participants Interval 0.17 to 31.95	33.3 Percent of participants Interval 0.84 to 90.57	25.0 Percent of participants Interval 3.19 to 65.09	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	57.1 Percent of participants Interval 18.41 to 90.1	33.3 Percent of participants Interval 7.49 to 70.07	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	25.0 Percent of participants Interval 3.19 to 65.09	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR	11.1 Percent of participants Interval 0.28 to 48.25	0 Percent of participants Lower limit and upper limit not calculated due to 0 participants with ORR

SECONDARY outcome

Timeframe: Up to approximately 25 months after the last dose

Population: All treated participants

OS is defined as the time from the date of the first dose to the date of death from any cause.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Overall Survival (OS)	4.93 Months Interval 2.86 to 7.0	8.27 Months Interval 5.29 to 11.24	8.02 Months Interval 7.1 to 8.94	2.79 Months Interval 0.3 to 3.25	1.91 Months Interval 1.18 to 3.45	8.28 Months Interval 0.66 to Insufficient number of participants with events to calculate upper limit	3.25 Months Interval 0.39 to 9.76	1.68 Months Interval 0.3 to 7.1	3.39 Months Interval 0.89 to 3.72	4.70 Months Interval 0.43 to 12.2	3.72 Months Interval 1.94 to Insufficient number of participants with events to calculate upper limit	4.18 Months Interval 0.46 to 5.98	1.28 Months Interval 0.3 to 3.75	7.81 Months Interval 7.59 to 8.02	2.43 Months Interval 0.39 to 5.42	2.30 Months Interval 0.3 to 4.47	NA Months Insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 25 months after the last dose

Population: All treated participants

RFS is defined only for participants who achieved CR or CRi (for AML) / CR or PR (for MDS) and is measured as the interval from the date of first CR or CRi (for AML) / CR or PR (for MDS) to the date of relapse or death from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Relapse-free Survival (RFS)	NA Months No participants with event	NA Months No participants with event	NA Months No participants with event	NA Months No participants with event	NA Months No participants with event	NA Months No participants with event	10.83 Months Interval 8.61 to 13.05	NA Months No participants with event	2.40 Months Insufficient number of participants with events	NA Months Interval 6.12 to Insufficient number of participants with events	NA Months No participants with event	NA Months No participants with event	3.02 Months Insufficient number of participants with events	NA Months No participants with event	NA Months No participants with event	NA Months No participants with event	NA Months No participants with event

SECONDARY outcome

Timeframe: Up to approximately 25 months after the last dose

Population: All treated participants

PFS is defined as the time from the date of the first dose to the date of first relapse after CR/CRi (for AML)/relapse after CR/PR(for MDS), or PD, or death resulting from any cause, whichever occurs first. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Progression-free Survival (PFS)	1.56 Months Interval 0.82 to 2.3	2.10 Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	1.74 Months Interval 0.3 to 3.25	1.35 Months Interval 0.79 to 2.79	1.02 Months Interval 0.66 to Insufficient number of participants with events	1.45 Months Interval 0.39 to 3.78	1.50 Months Interval 0.3 to 7.1	2.60 Months Interval 0.89 to 3.65	1.07 Months Interval 0.43 to Insufficient number of participants with events	1.94 Months Interval 0.95 to 2.33	2.33 Months Interval 0.46 to 2.93	1.07 Months Interval 0.3 to 3.75	7.81 Months Interval 7.59 to 8.02	0.90 Months Interval 0.3 to 1.71	2.30 Months Interval 0.3 to 3.75	1.84 Months Insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 25 months after the last dose

Population: All treated participants

EFS is defined as the interval from the date of the first dose to an event including disease progression (PD), treatment failure, relapse, or death from any cause, whichever occurs first. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=14 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=7 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Event-free Survival (EFS)	1.56 Months Interval 0.82 to 2.3	2.02 Months Interval 1.94 to 2.1	3.99 Months Interval 0.89 to 7.1	0.95 Months Interval 0.3 to 1.74	1.32 Months Interval 0.79 to 2.79	1.02 Months Interval 0.66 to 5.0	1.45 Months Interval 0.39 to 2.33	1.32 Months Interval 0.3 to 7.1	3.39 Months Interval 0.89 to 3.72	1.07 Months Interval 0.43 to 10.32	1.94 Months Interval 0.95 to 2.33	1.51 Months Interval 0.46 to 2.93	0.97 Months Interval 0.3 to 2.5	7.81 Months Interval 7.59 to 8.02	0.99 Months Interval 0.3 to 2.2	0.99 Months Interval 0.3 to 2.2	1.84 Months insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 25 months after the last dose

Population: All treated participants with response

DOR is defined as the time from first remission/response observed to the date of relapse, death or PD. PD=At least 50% decrement from maximum remission/response levels in granulocytes or platelets; Reduction in Hgb concentration by ≥ 2 g/dL; Transfusion dependence. Based on Kaplan-Meier Estimates.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=8 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=9 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=9 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Duration of Remission/Response (DOR)	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	1.32 Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Interval 3.16 to Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	3.02 Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events	NA Months Insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 25 months after the last dose

Population: All treated participants with available TTR results

TTR is defined as the time between the date of first dose and the earliest date any remission/response (any complete remissions or partial remissions or better) is observed. CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000 μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD; PR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts decrease in ≥ 50 resulting in 5 to 25%. Based on Kaplan-Meier Estimates.

Outcome measures

Measure	Part A - 0.3 mg Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=1 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=1 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=2 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=4 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=3 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=2 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=1 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Time to Remission/Response (TTR)	—	—	—	—	0.85 Months Interval 0.85 to 0.85	2.01 Months Interval 2.01 to 2.01	1.00 Months Interval 0.8 to 1.2	—	1.12 Months Interval 0.9 to 1.4	1.02 Months Interval 1.0 to 1.1	—	—	1.55 Months Interval 0.9 to 2.2	—	—	0.95 Months Interval 0.95 to 0.95	—

SECONDARY outcome

Timeframe: Up to approximately 88 months

Population: All treated participants with available CRR results

The complete remission rate (CRR) is defined as the percent of participants whose best overall response is any type of Morphologic Complete Remission [CR] (CR, Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Morphologic Complete Remission with Partial Hematologic Recovery (CRh), Cytogenetic Complete Remission (CRc) and Molecular Complete Remission (CRm)). CR=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; CRi=residual neutropenia < 1,000/μL, thrombocytopenia < 100,000/μL. CRh=neutrophils ≥ 500μL, platelets ≥500,000μL, blasts <5%; CRc=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%; cytogenetics normal; CRm=neutrophils ≥ 1,000μL, platelets ≥100,000μL, blasts <5%, negative EMD.

Outcome measures

Measure	Part A - 0.3 mg Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=1 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=1 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=2 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=2 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=2 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=8 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=1 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Complete Remission Rate (CRR)	—	—	—	—	6.7 Percent of participants Interval 0.17 to 31.95	33.3 Percent of participants Interval 0.84 to 90.57	25.0 Percent of participants Interval 3.19 to 65.09	—	28.6 Percent of participants Interval 3.67 to 70.96	22.2 Percent of participants Interval 2.81 to 60.01	—	—	12.5 Percent of participants Interval 0.32 to 52.65	—	—	11.1 Percent of participants Interval 0.28 to 48.25	—

SECONDARY outcome

Timeframe: Up to approximately 88 months

Population: All treated participants in part B - MDS only as pre-specified

Time to acute AML transformation in part B Myelodysplastic Syndromes (MDS) participants only. Based on Kaplan-Meier Estimates.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Time to Acute Myeloid Leukemia (AML) Transformation	4.88 Months Interval 4.6 to 5.1	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10,

Population: All treated participants with pharmacokinetic measurements

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

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=7 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=8 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=7 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=8 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=8 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Maximum Observed Plasma Concentration (Cmax) C1D1	17.21 ng/mL Geometric Coefficient of Variation 47.65	59.61 ng/mL Geometric Coefficient of Variation 19.21	71.30 ng/mL Geometric Coefficient of Variation 0.60	143.42 ng/mL Geometric Coefficient of Variation 356.59	106.23 ng/mL Geometric Coefficient of Variation 88.56	94.31 ng/mL Geometric Coefficient of Variation 75.89	90.77 ng/mL Geometric Coefficient of Variation 46.38	103.00 ng/mL Geometric Coefficient of Variation 26.22	122.02 ng/mL Geometric Coefficient of Variation 52.39	116.60 ng/mL Geometric Coefficient of Variation 276.56	129.53 ng/mL Geometric Coefficient of Variation 61.68	96.78 ng/mL Geometric Coefficient of Variation 42.25	179.97 ng/mL Geometric Coefficient of Variation 211.30	499.18 ng/mL Geometric Coefficient of Variation 2403.37	50.99 ng/mL Geometric Coefficient of Variation 59.25	73.94 ng/mL Geometric Coefficient of Variation 72.41	24.50 ng/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation
Maximum Observed Plasma Concentration (Cmax) C1D5	21.15 ng/mL Geometric Coefficient of Variation 1.67	47.19 ng/mL Geometric Coefficient of Variation 55.57	33.31 ng/mL Geometric Coefficient of Variation 90.26	120.48 ng/mL Geometric Coefficient of Variation 42.56	115.40 ng/mL Geometric Coefficient of Variation 93.25	82.40 ng/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation	147.16 ng/mL Geometric Coefficient of Variation 95.76	107.68 ng/mL Geometric Coefficient of Variation 17.50	—	—	—	—	—	—	—	—	—
Maximum Observed Plasma Concentration (Cmax) C1D7	—	—	—	—	—	—	—	—	156.65 ng/mL Geometric Coefficient of Variation 48.38	—	—	—	—	—	47.33 ng/mL Geometric Coefficient of Variation 75.83	99.57 ng/mL Geometric Coefficient of Variation 79.67	108.00 ng/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation
Maximum Observed Plasma Concentration (Cmax) C1D10	—	—	—	—	—	—	—	—	—	107.89 ng/mL Geometric Coefficient of Variation 28.36	—	—	—	—	—	—	—
Maximum Observed Plasma Concentration (Cmax) C1D8	—	—	—	—	—	—	—	—	—	—	215.18 ng/mL Geometric Coefficient of Variation 17.41	111.52 ng/mL Geometric Coefficient of Variation 29.72	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Time to peak plasma concentration, obtained directly from the observed concentration versus time data.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=7 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=8 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=7 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=8 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=8 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Time to Peak Plasma Concentration (Tmax) C1D1	0.050 hour Interval 0.05 to 0.05	0.058 hour Interval 0.05 to 0.07	0.042 hour Interval 0.03 to 0.05	0.667 hour Interval 0.57 to 1.13	0.617 hour Interval 0.25 to 0.98	0.250 hour Interval 0.25 to 0.43	0.350 hour Interval 0.25 to 1.1	0.767 hour Interval 0.67 to 1.33	0.750 hour Interval 0.25 to 0.82	0.750 hour Interval 0.25 to 0.78	0.750 hour Interval 0.25 to 0.75	0.783 hour Interval 0.25 to 0.98	0.767 hour Interval 0.25 to 1.0	0.783 hour Interval 0.77 to 0.8	0.783 hour Interval 0.23 to 1.03	0.800 hour Interval 0.37 to 24.1	1.083 hour Interval 1.083 to 1.083
Time to Peak Plasma Concentration (Tmax) C1D5	0.050 hour Interval 0.03 to 0.07	0.058 hour Interval 0.05 to 0.07	0.158 hour Interval 0.05 to 0.27	0.783 hour Interval 0.43 to 0.98	0.550 hour Interval 0.23 to 1.32	1.483 hour Interval 1.483 to 1.483	0.383 hour Interval 0.25 to 2.58	0.750 hour Interval 0.73 to 0.75	—	—	—	—	—	—	—	—	—
Time to Peak Plasma Concentration (Tmax) C1D7	—	—	—	—	—	—	—	—	0.583 hour Interval 0.25 to 0.8	—	—	—	—	—	1.067 hour Interval 0.77 to 4.42	0.775 hour Interval 0.6 to 1.12	0.667 hour Interval 0.667 to 0.667
Time to Peak Plasma Concentration (Tmax) C1D10	—	—	—	—	—	—	—	—	—	0.800 hour Interval 0.75 to 1.53	—	—	—	—	—	—	—
Time to Peak Plasma Concentration (Tmax) C1D8	—	—	—	—	—	—	—	—	—	—	0.750 hour Interval 0.5 to 0.78	0.733 hour Interval 0.28 to 1.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Area under the plasma concentration-time curve from Time 0 to 24 hours post-dose.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=15 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=3 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=7 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=7 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=8 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=7 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=8 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=8 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24) C1D1	22.93 h*ng/mL Geometric Coefficient of Variation 33.59	110.11 h*ng/mL Geometric Coefficient of Variation 68.80	121.06 h*ng/mL Geometric Coefficient of Variation 111.97	323.10 h*ng/mL Geometric Coefficient of Variation 75.44	382.59 h*ng/mL Geometric Coefficient of Variation 37.60	486.47 h*ng/mL Geometric Coefficient of Variation 70.83	333.79 h*ng/mL Geometric Coefficient of Variation 25.04	723.89 h*ng/mL Geometric Coefficient of Variation 30.43	618.99 h*ng/mL Geometric Coefficient of Variation 64.81	371.58 h*ng/mL Geometric Coefficient of Variation 87.80	304.37 h*ng/mL Geometric Coefficient of Variation 43.55	487.14 h*ng/mL Geometric Coefficient of Variation 69.15	835.2 h*ng/mL Geometric Coefficient of Variation 66.9	790.5 h*ng/mL Geometric Coefficient of Variation 250.4	245.53 h*ng/mL Geometric Coefficient of Variation 67.51	270.49 h*ng/mL Geometric Coefficient of Variation 102.71	188.00 h*ng/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24) C1D5	26.94 h*ng/mL Geometric Coefficient of Variation 35.62	141.84 h*ng/mL Geometric Coefficient of Variation 99.49	142.54 h*ng/mL Geometric Coefficient of Variation 148.76	769.03 h*ng/mL Geometric Coefficient of Variation 25.72	536.30 h*ng/mL Geometric Coefficient of Variation 39.55	1360.00 h*ng/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation	624.30 h*ng/mL Geometric Coefficient of Variation 55.31	669.55 h*ng/mL Geometric Coefficient of Variation 23.92	—	—	—	—	—	—	—	—	—
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24) C1D7	—	—	—	—	—	—	—	—	959.76 h*ng/mL Geometric Coefficient of Variation 80.24	—	—	—	—	—	369.61 h*ng/mL Geometric Coefficient of Variation 48.65	409.43 h*ng/mL Geometric Coefficient of Variation 54.13	425.00 h*ng/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24) C1D10	—	—	—	—	—	—	—	—	—	777.69 h*ng/mL Geometric Coefficient of Variation 14.64	—	—	—	—	—	—	—
Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose (AUC 0 - 24) C1D8	—	—	—	—	—	—	—	—	—	—	422.26 h*ng/mL Geometric Coefficient of Variation 41.02	648.01 h*ng/mL Geometric Coefficient of Variation 35.29	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Terminal phase elimination half-life calculated as [(ln 2)/λz], where λz is the apparent terminal rate constant. t1/2 will only be calculated when a reliable estimate for λz can be obtained.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=14 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=2 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=6 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=6 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=8 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=7 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=6 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=6 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Terminal Phase Elimination Half-life (T1/2) C1D1	3.783 hour Interval 2.61 to 4.96	7.717 hour Interval 6.43 to 9.01	7.295 hour Interval 3.6 to 10.99	5.991 hour Interval 3.92 to 11.88	6.317 hour Interval 3.68 to 10.61	6.864 hour Interval 4.97 to 8.76	4.001 hour Interval 3.7 to 4.98	8.378 hour Interval 5.35 to 13.45	6.584 hour Interval 3.86 to 8.54	3.739 hour Interval 3.46 to 11.48	4.649 hour Interval 4.28 to 5.61	6.795 hour Interval 3.51 to 9.75	6.246 hour Interval 3.01 to 15.47	6.844 hour Interval 4.74 to 8.94	6.432 hour Interval 2.47 to 8.39	4.800 hour Interval 3.5 to 10.78	7.737 hour Interval 7.737 to 7.737

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1), C1D5, C1D7, C1D8, C1D10. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Total plasma clearance after IV administration, calculated as [Dose/ AUC(INF)] following single administration, and [Dose/ AUC(0-24)] at steady state.

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=14 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=2 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=7 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=6 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=8 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=7 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=6 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=8 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Total Body Clearance (CL) C1D1	12.684 L/h Geometric Coefficient of Variation 38.525	4.868 L/h Geometric Coefficient of Variation 75.331	8.796 L/h Geometric Coefficient of Variation 143.853	6.882 L/h Geometric Coefficient of Variation 74.110	7.352 L/h Geometric Coefficient of Variation 43.454	6.140 L/h Geometric Coefficient of Variation 125.199	11.105 L/h Geometric Coefficient of Variation 24.102	5.932 L/h Geometric Coefficient of Variation 24.699	5.418 L/h Geometric Coefficient of Variation 69.589	7.551 L/h Geometric Coefficient of Variation 94.257	9.618 L/h Geometric Coefficient of Variation 42.482	6.828 L/h Geometric Coefficient of Variation 77.163	3.809 L/h Geometric Coefficient of Variation 71.852	4.359 L/h Geometric Coefficient of Variation 265.439	9.817 L/h Geometric Coefficient of Variation 73.556	11.494 L/h Geometric Coefficient of Variation 105.754	9.350 L/h Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation
Total Body Clearance (CL) C1D5	11.134 L/h Geometric Coefficient of Variation 35.442	4.238 L/h Geometric Coefficient of Variation 99.224	8.423 L/h Geometric Coefficient of Variation 149.082	3.120 L/h Geometric Coefficient of Variation 25.689	5.594 L/h Geometric Coefficient of Variation 39.561	2.650 L/h Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation	5.772 L/h Geometric Coefficient of Variation 55.283	6.721 L/h Geometric Coefficient of Variation 23.895	—	—	—	—	—	—	—	—	—
Total Body Clearance (CL) C1D7	—	—	—	—	—	—	—	—	3.751 L/h Geometric Coefficient of Variation 80.086	—	—	—	—	—	5.910 L/h Geometric Coefficient of Variation 44.624	6.615 L/h Geometric Coefficient of Variation 57.381	7.060 L/h Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation
Total Body Clearance (CL) C1D10	—	—	—	—	—	—	—	—	—	3.857 L/h Geometric Coefficient of Variation 14.571	—	—	—	—	—	—	—
Total Body Clearance (CL) C1D8	—	—	—	—	—	—	—	—	—	—	7.098 L/h Geometric Coefficient of Variation 40.903	5.553 L/h Geometric Coefficient of Variation 35.415	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1) and C1D5. 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Volume of distribution calculated at first dose only. Calculated as [Vz = Dose/ AUC(INF) * λz for Day 1].

Outcome measures

Measure	Part A - 0.3 mg n=2 Participants Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg n=2 Participants Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg n=2 Participants Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg n=7 Participants Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=14 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg n=2 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX n=6 Participants Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg n=6 Participants Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 Participants Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=8 Participants Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX n=7 Participants Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=6 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=6 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Volume of Distribution (Vz) C1D1	65.74 L Geometric Coefficient of Variation 8.29	53.38 L Geometric Coefficient of Variation 45.41	79.87 L Geometric Coefficient of Variation 27.70	64.51 L Geometric Coefficient of Variation 82.15	68.28 L Geometric Coefficient of Variation 32.16	58.48 L Geometric Coefficient of Variation 62.34	65.80 L Geometric Coefficient of Variation 20.59	70.30 L Geometric Coefficient of Variation 28.14	46.58 L Geometric Coefficient of Variation 41.72	55.03 L Geometric Coefficient of Variation 73.60	66.95 L Geometric Coefficient of Variation 55.61	60.12 L Geometric Coefficient of Variation 41.69	33.559 L Geometric Coefficient of Variation 70.261	40.973 L Geometric Coefficient of Variation 129.680	77.996 L Geometric Coefficient of Variation 37.418	86.419 L Geometric Coefficient of Variation 99.105	104.000 L Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation

SECONDARY outcome

Timeframe: Cycle 1 Day 1(C1D1). 1 cycle = 28 days

Population: All treated participants with pharmacokinetic measurements

Renal clearance of CC-90009 (CLr)

Outcome measures

Measure	Part A - 0.3 mg Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg Part A - 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg n=14 Participants Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 Participants Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 Participants Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - AML 3.6 mg + DEX Part B - 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX n=2 Participants Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)	Part B - AML 2.4 mg n=6 Participants Part B - 2.4 mg (Days 1 - 7 of 28)	Part B - AML 3.0 mg n=6 Participants Part B - 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg n=1 Participants Part B - MDS 3.0 mg (Days 1 - 7 of 28)
Renal Clearance (CLr)	—	—	—	—	0.63900 L/h Geometric Coefficient of Variation 200.50356	—	—	—	—	—	0.61571 L/h Geometric Coefficient of Variation 219.79379	1.10066 L/h Geometric Coefficient of Variation 38.74255	—	40.973 L/h Geometric Coefficient of Variation 129.680	77.996 L/h Geometric Coefficient of Variation 37.418	86.419 L/h Geometric Coefficient of Variation 99.105	104.000 L/h Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric coefficient of variation

Adverse Events

Part A - 0.3 mg (Days 1 - 5 of 28)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Part A - 0.6 mg (Days 1 - 5 of 28)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Part A - 1.2 mg (Days 1 - 5 of 28)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Part A - 2.4 mg (Days 1 - 5 of 28)

Serious events: 6 serious events

Other events: 7 other events

Deaths: 7 deaths

Part A - 3.0 mg (Days 1 - 5 of 28)

Serious events: 15 serious events

Other events: 15 other events

Deaths: 14 deaths

Part A - 3.6 mg (Days 1 - 5 of 28)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A - 3.6 mg + DEX (Days 1 - 5 of 28)

Serious events: 7 serious events

Other events: 8 other events

Deaths: 8 deaths

Part A - 4.5 mg (Days 1 - 5 of 28)

Serious events: 7 serious events

Other events: 7 other events

Deaths: 6 deaths

Part A - 3.6 mg (Days 1 - 7 of 28)

Serious events: 7 serious events

Other events: 7 other events

Deaths: 7 deaths

Part A - 3.0 mg (Days 1- 10 of 28)

Serious events: 6 serious events

Other events: 9 other events

Deaths: 7 deaths

Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28)

Serious events: 6 serious events

Other events: 7 other events

Deaths: 7 deaths

Part B - 3.6 mg + DEX (Days 1 - 5 of 28)

Serious events: 8 serious events

Other events: 8 other events

Deaths: 8 deaths

Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Part B - 2.4 mg (Days 1 - 7 of 28)

Serious events: 9 serious events

Other events: 8 other events

Deaths: 9 deaths

Part B - 3.0 mg (Days 1 - 7 of 28)

Serious events: 8 serious events

Other events: 9 other events

Deaths: 9 deaths

Part B - MDS 3.0 mg (Days 1 - 7 of 28)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A - 0.3 mg (Days 1 - 5 of 28) n=2 participants at risk Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg (Days 1 - 5 of 28) n=2 participants at risk Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg (Days 1 - 5 of 28) n=2 participants at risk Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg (Days 1 - 5 of 28) n=7 participants at risk Part A - CC-90009 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg (Days 1 - 5 of 28) n=15 participants at risk Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 5 of 28) n=3 participants at risk Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX (Days 1 - 5 of 28) n=8 participants at risk Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg (Days 1 - 5 of 28) n=7 participants at risk Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 participants at risk Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 participants at risk Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 participants at risk Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 participants at risk Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - 3.6 mg + DEX (Days 1 - 5 of 28) n=8 participants at risk Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28) n=2 participants at risk Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)	Part B - 2.4 mg (Days 1 - 7 of 28) n=9 participants at risk Part B - MDS CC-90009 24 mg (Days 1 - 7 of 28)	Part B - 3.0 mg (Days 1 - 7 of 28) n=9 participants at risk Part B - CC-90009 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg (Days 1 - 7 of 28) n=1 participants at risk Part B - MDS CC-90009 3.0 mg (Days 1 - 7 of 28)
Infections and infestations Clostridium difficile infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	62.5% 5/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Splenic infarction	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Arrhythmia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Atrial fibrillation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Cardiac arrest	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Pericarditis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Pulseless electrical activity	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Colitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Nausea	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Neutropenic colitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Stomatitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Volvulus	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Fatigue	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders General physical health deterioration	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Multiple organ dysfunction syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Device related bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Pyrexia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Systemic inflammatory response syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Anal infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Bacterial sepsis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Catheter site infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Cellulitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Citrobacter infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Clostridium difficile colitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Device related infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Device related sepsis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Enterobacter infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Enterococcal bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Escherichia bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Escherichia sepsis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Eye infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Klebsiella bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Klebsiella sepsis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Oral infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Pneumonia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Pneumonia fungal	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Pneumonia pseudomonal	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Pneumonia viral	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Pseudomonal bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Sepsis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Sepsis syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Septic shock	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Sinusitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Staphylococcal bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Stenotrophomonas infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Stenotrophomonas sepsis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Urinary tract infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood bilirubin increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood creatinine increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations C-reactive protein increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations SARS-CoV-2 test positive	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Diabetic hyperosmolar coma	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Haemorrhage intracranial	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Presyncope	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Syncope	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Haematuria	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Hypertension	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Hypotension	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Orthostatic hypotension	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).

Other adverse events

Measure	Part A - 0.3 mg (Days 1 - 5 of 28) n=2 participants at risk Part A - CC-90009 QD 0.3 mg (Days 1 - 5 of 28)	Part A - 0.6 mg (Days 1 - 5 of 28) n=2 participants at risk Part A - CC-90009 QD 0.6 mg (Days 1 - 5 of 28)	Part A - 1.2 mg (Days 1 - 5 of 28) n=2 participants at risk Part A - CC-90009 QD 1.2 mg (Days 1 - 5 of 28)	Part A - 2.4 mg (Days 1 - 5 of 28) n=7 participants at risk Part A - CC-90009 2.4 mg (Days 1 - 5 of 28)	Part A - 3.0 mg (Days 1 - 5 of 28) n=15 participants at risk Part A - CC-90009 QD 3.0 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 5 of 28) n=3 participants at risk Part A - CC-90009 QD 3.6 mg (Days 1 - 5 of 28)	Part A - 3.6 mg + DEX (Days 1 - 5 of 28) n=8 participants at risk Part A - CC-90009 QD 3.6 mg + Dexamethasone 10 mg IV (Days 1 - 5 of 28)	Part A - 4.5 mg (Days 1 - 5 of 28) n=7 participants at risk Part A - CC-90009 daily (QD) 4.5 mg (Days 1 - 5 of 28)	Part A - 3.6 mg (Days 1 - 7 of 28) n=7 participants at risk Part A - CC-90009 QD 3.6 mg (Days 1 - 7 of 28)	Part A - 3.0 mg (Days 1- 10 of 28) n=9 participants at risk Part A - CC-90009 QD 3.0 mg (Days 1- 10 of 28)	Part A - 3.0 mg (Day 1 - 3 & Day 8 - 10 of 28) n=3 participants at risk Part A - CC-90009 daily (QD) 3.0 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part A - 3.6 mg (Day 1 - 3 & Day 8 - 10 of 28) n=7 participants at risk Part A - CC-90009 daily (QD) 3.6 mg (Day 1 - 3 \& Day 8 - 10 of 28)	Part B - 3.6 mg + DEX (Days 1 - 5 of 28) n=8 participants at risk Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)	Part B - MDS 3.6 mg + DEX (Days 1 - 5 of 28) n=2 participants at risk Part B - MDS CC-90009 3.6 mg + Dexamethasone (Days 1 - 5 of 28)	Part B - 2.4 mg (Days 1 - 7 of 28) n=9 participants at risk Part B - MDS CC-90009 24 mg (Days 1 - 7 of 28)	Part B - 3.0 mg (Days 1 - 7 of 28) n=9 participants at risk Part B - CC-90009 3.0 mg (Days 1 - 7 of 28)	Part B - MDS 3.0 mg (Days 1 - 7 of 28) n=1 participants at risk Part B - MDS CC-90009 3.0 mg (Days 1 - 7 of 28)
Gastrointestinal disorders Faeces discoloured	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Clostridium difficile infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Conjunctivitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Headache	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Coagulopathy	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Cytopenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Leukocytosis	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Leukopenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Splenic infarction	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Angina pectoris	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Arrhythmia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Atrial fibrillation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Atrioventricular block second degree	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Bradycardia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Dilated cardiomyopathy	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Pericardial effusion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Sinus bradycardia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Tachycardia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Cardiac disorders Ventricular extrasystoles	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Ear and labyrinth disorders Hypoacusis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Ear and labyrinth disorders Tinnitus	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Ear and labyrinth disorders Vertigo	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Ear and labyrinth disorders Vertigo positional	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Endocrine disorders Adrenal insufficiency	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Endocrine disorders Hyperparathyroidism	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Endocrine disorders Hypoparathyroidism	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Eye disorders Eye pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Eye disorders Periorbital oedema	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Eye disorders Scleritis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Eye disorders Vision blurred	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Eye disorders Visual impairment	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Anal incontinence	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Ascites	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Colitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Constipation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Diarrhoea	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 10/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 3/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	62.5% 5/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	85.7% 6/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 7/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 2/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	55.6% 5/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Dry mouth	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Enterocolitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Faecaloma	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Flatulence	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Gastritis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Gastrointestinal necrosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Gingival hypertrophy	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Haemorrhoids	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Nausea	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 2/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	71.4% 5/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	60.0% 9/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	85.7% 6/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	71.4% 5/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 6/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 3/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 2/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	77.8% 7/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Neutropenic colitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Odynophagia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Oral disorder	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Oral pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Proctalgia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Proctitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Stomatitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Tongue haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Gastrointestinal disorders Vomiting	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	53.3% 8/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Asthenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Axillary pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Catheter site erythema	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Catheter site inflammation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Catheter site pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Chest discomfort	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Chest pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Chills	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Cyst	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Facial pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Fatigue	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	55.6% 5/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Feeling cold	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Gait disturbance	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders General physical health deterioration	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Hyperthermia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Hypothermia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Illness	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Infusion site extravasation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Injection site pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Localised oedema	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Mucosal haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Mucosal inflammation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Multiple organ dysfunction syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Non-cardiac chest pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Oedema	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Oedema peripheral	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Pain	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
General disorders Pyrexia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Hepatobiliary disorders Gallbladder oedema	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Hepatobiliary disorders Hepatotoxicity	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Hepatobiliary disorders Jaundice	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Immune system disorders Cytokine release syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Immune system disorders Cytokine storm	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Immune system disorders Graft versus host disease in skin	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Immune system disorders Hypersensitivity	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Acinetobacter bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Anal abscess	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations COVID-19	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Candida infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Catheter site infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Cellulitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Clostridium difficile colitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Diverticulitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Enterococcal bacteraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Enterocolitis infectious	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Folliculitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Herpes simplex	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Infected cyst	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Lip infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Lower respiratory tract infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Metapneumovirus infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Mucosal infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Neutropenic sepsis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Oral candidiasis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Oral herpes	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Oropharyngeal candidiasis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Pneumonia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Postoperative wound infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Respiratory tract infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Salmonellosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Sialoadenitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Sinusitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Staphylococcal infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Subcutaneous abscess	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Tooth infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Urinary tract infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Infections and infestations Vascular device infection	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Fall	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Head injury	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Limb injury	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Hemiparesis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Activated partial thromboplastin time prolonged	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Alanine aminotransferase increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Aspartate aminotransferase increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Bilirubin conjugated increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood bicarbonate decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood bilirubin increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood bilirubin unconjugated increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood creatinine increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	55.6% 5/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood fibrinogen decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood glucose increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood lactate dehydrogenase increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood lactic acid increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood parathyroid hormone decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood phosphorus increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood urea increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Blood uric acid decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Brain natriuretic peptide increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations C-reactive protein increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Calcium ionised decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Cardiac murmur	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Chest X-ray abnormal	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Clostridium test positive	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Coagulation time prolonged	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Ejection fraction decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Electrocardiogram QRS complex abnormal	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Electrocardiogram QT shortened	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Electrocardiogram ST segment abnormal	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Electrocardiogram T wave inversion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Haemoglobin decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations International normalised ratio increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Lipase increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Lymphocyte count decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Lymphocyte count increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Neutrophil count decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Neutrophil count increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Occult blood positive	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Platelet count decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Protein total decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Staphylococcus test positive	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Transaminases increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Troponin I increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Troponin increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Vitamin D decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Weight decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations Weight increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations White blood cell count decreased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Investigations White blood cell count increased	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Acidosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Cachexia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Decreased appetite	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 2/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Folate deficiency	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hyperferritinaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	71.4% 5/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hyperuricaemia	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	55.6% 5/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypocalcaemia	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	73.3% 11/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 3/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	75.0% 6/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 7/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 7/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	88.9% 8/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 3/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	71.4% 5/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	75.0% 6/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 2/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	55.6% 5/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	77.8% 7/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypokalaemia	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	71.4% 5/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	55.6% 5/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypophagia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	26.7% 4/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	57.1% 4/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypoproteinaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Refeeding syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Metabolism and nutrition disorders Vitamin K deficiency	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Sarcopenia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia cutis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Dizziness	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	44.4% 4/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Dysgeusia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Lethargy	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Memory impairment	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Nerve compression	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Neuropathy peripheral	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Optic neuritis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Paraesthesia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Presyncope	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Sinus headache	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Syncope	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Taste disorder	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Nervous system disorders Tremor	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Product Issues Device leakage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Agitation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Anxiety	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Confusional state	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Delirium	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Delusion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Depression	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Hallucination	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Insomnia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	13.3% 2/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Mental status changes	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Psychiatric disorders Restlessness	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Chronic kidney disease	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Dysuria	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Haematuria	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Pollakiuria	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Polyuria	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Proteinuria	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Renal failure	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Renal impairment	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Urinary incontinence	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Renal and urinary disorders Urinary retention	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	20.0% 3/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Acne	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Madarosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Skin haemorrhage	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Stasis dermatitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Deep vein thrombosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Embolism	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Flushing	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Haematoma	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Hot flush	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Hypertension	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Hypotension	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	60.0% 9/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	66.7% 2/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	85.7% 6/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	85.7% 6/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	55.6% 5/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	50.0% 1/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	22.2% 2/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 3/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	100.0% 1/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Hypovolaemic shock	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Lymphoedema	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Orthostatic hypotension	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	6.7% 1/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Pallor	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Thrombophlebitis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	11.1% 1/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).
Vascular disorders Thrombosis	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/15 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	33.3% 1/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/3 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/2 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/9 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).	0.00% 0/1 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months). SAEs and Other AEs were assessed from first dose to 28 days post the last dose (up to approximately 25 months).

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