Trial Outcomes & Findings for A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis. (NCT NCT01146574)

NCT ID: NCT01146574

Last Updated: 2024-03-01

Results Overview

Cmax is a pharmacokinetic parameter defined as the observed maximum concentration of the study drug in the serum and/or blood. Cmax will be estimated from the sotatercept concentration versus time data using noncompartmental method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

From first dose up to Day 28

Results posted on

2024-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Overall Study STARTED	1	6	11	9	8	9	6
Overall Study COMPLETED	1	5	5	7	6	8	5
Overall Study NOT COMPLETED	0	1	6	2	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Overall Study Death	0	1	1	0	0	0	0
Overall Study Other reasons	0	0	3	0	0	0	0
Overall Study Kidney transplant	0	0	1	1	0	0	0
Overall Study Withdrew consent	0	0	1	1	2	1	1

Baseline Characteristics

A Phase 2a Study To Evaluate The Pharmacokinetics, Safety, Efficacy, Tolerability, And Pharmacodynamics of Sotatercept (ACE-011) for the Correction of Anemia in Subjects With End-stage Renal Disease on Hemodialysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1-Placebo n=1 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=11 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	5 Participants n=107 Participants	9 Participants n=206 Participants	7 Participants n=7 Participants	6 Participants n=31 Participants	5 Participants n=30 Participants	4 Participants n=3 Participants	37 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants	2 Participants n=31 Participants	4 Participants n=30 Participants	2 Participants n=3 Participants	13 Participants n=6 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants	6 Participants n=7 Participants	1 Participants n=31 Participants	7 Participants n=30 Participants	1 Participants n=3 Participants	21 Participants n=6 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants	3 Participants n=7 Participants	7 Participants n=31 Participants	2 Participants n=30 Participants	5 Participants n=3 Participants	29 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants	4 Participants n=31 Participants	2 Participants n=30 Participants	1 Participants n=3 Participants	11 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants	7 Participants n=7 Participants	4 Participants n=31 Participants	7 Participants n=30 Participants	5 Participants n=3 Participants	39 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=3 Participants	3 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	0 Participants n=3 Participants	1 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants	6 Participants n=7 Participants	4 Participants n=31 Participants	1 Participants n=30 Participants	4 Participants n=3 Participants	24 Participants n=6 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	3 Participants n=7 Participants	4 Participants n=31 Participants	7 Participants n=30 Participants	1 Participants n=3 Participants	22 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: From first dose up to Day 28

Population: Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered.

Cmax is a pharmacokinetic parameter defined as the observed maximum concentration of the study drug in the serum and/or blood. Cmax will be estimated from the sotatercept concentration versus time data using noncompartmental method.

Outcome measures

Outcome measures
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Observed Maximum Concentration (Cmax)	—	1.022 ug/mL Standard Deviation 0.576	—	2.40 ug/mL Standard Deviation 0.96	3.66 ug/mL Standard Deviation 0.67	3.97 ug/mL Standard Deviation 1.64	7.71 ug/mL Standard Deviation 1.97

PRIMARY outcome

Timeframe: From first dose up to Day 28

Population: Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered.

Time to observed maximum concentration (Tmax) is defined as the amount of time in days for a drug to reach the maximum concentration after administration.

Outcome measures

Outcome measures
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Time to Maximum Concentration (Tmax)	—	6 Days Interval 3.0 to 14.0	—	7 Days Interval 3.0 to 14.0	8 Days Interval 4.0 to 12.0	7 Days Interval 4.0 to 10.0	5 Days Interval 3.0 to 13.0

PRIMARY outcome

Timeframe: From first dose up to Day 28

Population: Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered.

AUC-28 days is defined as area under the concentration-time curve over the first 28-day dosing interval

Outcome measures

Outcome measures
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=5 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Area Under Curve (AUC)-28 Days	—	20.6 ug·day/mL Standard Deviation 11.4	—	50.64 ug·day/mL Standard Deviation 17.67	78.03 ug·day/mL Standard Deviation 13.34	87.51 ug·day/mL Standard Deviation 36.68	126.96 ug·day/mL Standard Deviation 20.75

PRIMARY outcome

Timeframe: From first dose up to Day 28

Population: Pre-specified in the protocol to be collected in Part 1 pharmacokinetic evaluable participants only. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered.

Area under the concentration-time curve from time zero extrapolated to infinity. Only Part 1 pharmacokinetic evaluable participants were pre-specified to be evaluated in this endpoint.

Outcome measures

Outcome measures
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
AUCinf: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity	—	35.8 ug·day/mL Standard Deviation 17.4	—	—	—	—	—

PRIMARY outcome

Timeframe: From first dose up to Day 28

Population: Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered.

Apparent Total Clearance (CL/F) is defined as the volume of plasma from which the study drug is completely removed per unit of time. It is equal to the drug dose divided by the area-under-the-curve.

Outcome measures

Outcome measures
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Apparent Total Clearance (CL/F)	—	3.22 L/day Standard Deviation 1.20	—	0.255 L/day Standard Deviation 0.068	0.261 L/day Standard Deviation 0.075	0.532 L/day Standard Deviation 0.654	0.298 L/day Standard Deviation 0.112

PRIMARY outcome

Timeframe: From first dose up to Day 28

Population: Pre-specified in the protocol to be collected in Part 1 pharmacokinetic evaluable participants only. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered.

Apparent volume of distribution based on terminal phase (Vz/F) is defined as the apparent volume in which the current amount of drug in the body must be dispersed in order to give the current plasma concentration. Apparent volume of distribution is important for determining the dose required to produce a desired plasma concentration of the drug.

Outcome measures

Outcome measures
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Apparent Volume of Distribution Based on Terminal Phase (Vz/F)	—	98 mL/kg Standard Deviation 38	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 85 and 113

Population: Participants with evaluable pharmacokinetic data. Pharmacokinetic data was not recorded for participants who received placebo because no study drug was administered.

Terminal plasma half-life (t1/2,z) is the time taken for concentration of the study drug to decrease from its maximum concentration (Cmax) to half of Cmax in the blood plasma.

Outcome measures

Outcome measures
Measure	Part 1-Placebo Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Terminal Half-Life (t1/2,z)	—	21.1 Day Standard Deviation 3.9	—	24.3 Day Standard Deviation 3.28	32.1 Day Standard Deviation 19.9	22.2 Day Standard Deviation 7.00	19.6 Day Standard Deviation 2.91

SECONDARY outcome

Timeframe: From first dose up to 115 days post last dose

Population: All randomized participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=1 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=11 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
The Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)	1 Participants	6 Participants	7 Participants	8 Participants	6 Participants	8 Participants	4 Participants

SECONDARY outcome

Timeframe: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309

Population: All randomized participants

Number of participants with hemoglobin \> 12g/dL including Hb values obtained after first study drug dose and before any rescue.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=1 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=11 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Number of Participants With Hemoglobin > 12g/dL	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309

Population: All randomized participants

Proportion of participants with rise in hemoglobin (Hb) \> 2 g/dL during a 4-week period including Hb values obtained after first study drug dose and before any rescue.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=1 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=11 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Proportion of Participants With Rise in Hemoglobin > 2 g/dL During 4 Week Period	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From pre-dose up to the final visit 112 days after last dose (up to 225 days)

Population: Safety population- all randomized participant who received at least 1 dose of sotatercept and had evaluable safety data

Blood pressure was generally recorded on the day of dialysis and represent pre-dialysis values. Baseline is defined as blood pressure measurements recorded on Day 1 of the first dose administered.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=1 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=9 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=8 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg n=6 Participants Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Blood Pressure Changes From Baseline Diastolic Blood Pressure Final Visit	83.0 mmHg Standard Deviation NA Standard deviation not calculated due to insufficient number of participants.	86.2 mmHg Standard Deviation 15.93	79.7 mmHg Standard Deviation 15.53	85.2 mmHg Standard Deviation 9.83	83.6 mmHg Standard Deviation 18.98	75.3 mmHg Standard Deviation 9.19	71.6 mmHg Standard Deviation 10.01
Blood Pressure Changes From Baseline Systolic Blood Pressure Baseline Day 1	151.0 mmHg Standard Deviation NA Standard deviation not calculated due to insufficient number of participants.	142.8 mmHg Standard Deviation 13.11	129.4 mmHg Standard Deviation 27.99	145.9 mmHg Standard Deviation 9.75	141.4 mmHg Standard Deviation 18.72	139.9 mmHg Standard Deviation 29.25	135.0 mmHg Standard Deviation 25.09
Blood Pressure Changes From Baseline Systolic Blood Pressure Final Visit	163.0 mmHg Standard Deviation NA Standard deviation not calculated due to insufficient number of participants.	134.6 mmHg Standard Deviation 6.95	145.0 mmHg Standard Deviation 26.91	167.0 mmHg Standard Deviation 12.81	154.0 mmHg Standard Deviation 34.47	154.3 mmHg Standard Deviation 22.93	131.8 mmHg Standard Deviation 12.79
Blood Pressure Changes From Baseline Diastolic Blood Pressure Baseline Day 1	75.0 mmHg Standard Deviation NA Standard deviation not calculated due to insufficient number of participants.	81.5 mmHg Standard Deviation 7.56	71.6 mmHg Standard Deviation 13.42	78.2 mmHg Standard Deviation 12.45	74.3 mmHg Standard Deviation 8.41	64.6 mmHg Standard Deviation 13.33	72.0 mmHg Standard Deviation 16.10

SECONDARY outcome

Timeframe: Day 1 (baseline), Day 15, Day 29, and Day 113

Population: All randomized participants in Part 1

The change in follicle stimulating measured at pre-specified timepoints throughout the treatment period.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=1 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=6 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Changes in Follicle Stimulating Hormone (FSH) Day 1 (baseline)	23.5 IU/L Standard Deviation NA Standard deviation not calculated due to insufficient number of participants	36.9 IU/L Standard Deviation 67.65	—	—	—	—	—
Changes in Follicle Stimulating Hormone (FSH) Day 15	17.1 IU/L Standard Deviation NA Standard deviation not calculated due to insufficient number of participants	51.8 IU/L Standard Deviation 80.76	—	—	—	—	—
Changes in Follicle Stimulating Hormone (FSH) Day 29	17.5 IU/L Standard Deviation NA Standard deviation not calculated due to insufficient number of participants	37.4 IU/L Standard Deviation 67.69	—	—	—	—	—
Changes in Follicle Stimulating Hormone (FSH) Day 113	11.8 IU/L Standard Deviation NA Standard deviation not calculated due to insufficient number of participants	48.2 IU/L Standard Deviation 78.81	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309

Population: All randomized participants in Part 2

Number of participants with hemoglobin \> 10g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=11 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=9 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=8 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=6 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Number of Participants With Hemoglobin > 10g/dL	3 Participants	3 Participants	5 Participants	7 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309

Population: All randomized participants in Part 2

Number of participants with a change from in hemoglobin values ≥ 1g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=11 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=9 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=8 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=6 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Number of Participants With Change From Baseline Hemoglobin ≥ 1g/dL	2 Participants	3 Participants	4 Participants	7 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: Pre-dose; Dose 1-Days 1, 8, 15, 22, 29; Doses 2, 3, 4, 5, 6, 7-Days 1, 15, 29; Follow-up Phase Days 225, 253, 281, and 309

Population: All randomized participants in Part 2

Number of participants with Hemoglobin \> 10g/dL and a change from in hemoglobin values ≥ 1g/dL including Hb values obtained after first study drug dose and before any rescue. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=11 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=9 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=8 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=6 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Number of Participants With Hemoglobin > 10g/dL and Change From Baseline Hemoglobin ≥ 1g/dL	2 Participants	2 Participants	4 Participants	6 Participants	2 Participants	—	—

SECONDARY outcome

Timeframe: From first dose up to blood transfusion or ESA therapy, up to approximately 209 days

Population: Participants in Part 2 who received rescue therapy

The length of time in days that participants who were rescued received treatment. When applicable, participants were rescued for anemia. During the rescue, participants discontinued sotatercept and were unblinded to the study treatment. Participants who were rescued continued in the treatment phase of 200 days and a follow-up phase of 112 days after the treatment phase. Rescue is defined as the need for a blood transfusion or Erythropoiesis-stimulating agent (ESA) therapy.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=10 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=8 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=5 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=5 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=6 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Length of Time to Rescue Therapy	44.8 Days Standard Deviation 43.96	69.8 Days Standard Deviation 59.12	47.4 Days Standard Deviation 32.86	100.4 Days Standard Deviation 55.73	117.5 Days Standard Deviation 73.37	—	—

SECONDARY outcome

Timeframe: From first dose up to Day 225

Population: All randomized participants in Part 2

Dose Cycle 1 is defined as the first 28 days of treatment for Dose Groups 0.3 mg/kg, 0.5 mg/kg, and 0.7 mg/kg and the first 14 days of treatment for Dose Group 0.7/0.4 mg/kg. End of the Treatment Period is defined as the day before the follow-up phase started. Baseline is defined as hemoglobin measurements recorded on Day 1 of the first dose administered.

Outcome measures

Outcome measures
Measure	Part 1-Placebo n=11 Participants Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1-ACE-011 0.1 mg/kg n=9 Participants Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2- Placebo n=8 Participants Participants received a single subcutaneous dose of placebo	Part 2-0.3 mg/kg n=9 Participants Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.5 mg/kg n=6 Participants Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7 mg/kg Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2-0.7/0.4 mg/kg Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Change From Baseline in Hemoglobin Values End of Dose Cycle 1	-3.3 g/L Standard Deviation 7.57	-6.9 g/L Standard Deviation 6.94	-2.9 g/L Standard Deviation 8.18	0.8 g/L Standard Deviation 5.85	1.0 g/L Standard Deviation 2.45	—	—
Change From Baseline in Hemoglobin Values Peak Value During Dose Cycle 1	-0.9 g/L Standard Deviation 7.08	5.2 g/L Standard Deviation 8.24	7.1 g/L Standard Deviation 3.98	8.4 g/L Standard Deviation 3.75	5.4 g/L Standard Deviation 4.10	—	—
Change From Baseline in Hemoglobin Values End of Treatment Period	12.5 g/L Standard Deviation 12.42	12.8 g/L Standard Deviation 13.75	15.3 g/L Standard Deviation 8.22	15.0 g/L Standard Deviation 12.11	2.8 g/L Standard Deviation 6.91	—	—

Adverse Events

Part 1 - Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1 - ACE-011 0.1 mg/kg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Part 2 - Placebo

Serious events: 3 serious events

Other events: 6 other events

Deaths: 2 deaths

Part 2 - 0.3 mg/kg

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2 - 0.5 mg/kg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2 - 0.7 mg/kg

Serious events: 5 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2 - 0.7/0.4 mg/kg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1 - Placebo n=1 participants at risk Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1 - ACE-011 0.1 mg/kg n=6 participants at risk Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2 - Placebo n=11 participants at risk Participants received a single subcutaneous dose of placebo	Part 2 - 0.3 mg/kg n=9 participants at risk Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2 - 0.5 mg/kg n=8 participants at risk Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2 - 0.7 mg/kg n=9 participants at risk Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2 - 0.7/0.4 mg/kg n=6 participants at risk Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Cardiac disorders ANGINA UNSTABLE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Blood and lymphatic system disorders ANAEMIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Cardiac disorders ANGINA PECTORIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	18.2% 2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Cardiac disorders ARTERIOSCLEROSIS CORONARY ARTERY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Cardiac disorders CARDIOMYOPATHY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders ILEUS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders NAUSEA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders VOMITING	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders GAIT DISTURBANCE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders OEDEMA PERIPHERAL	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations GASTROENTERITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations OESOPHAGEAL CANDIDIASIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations PNEUMONIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations TRACHEOBRONCHITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications FALL	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations HEART RATE IRREGULAR	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR THROMBOSIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Vascular disorders AORTIC ANEURYSM	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Vascular disorders HYPERTENSION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Vascular disorders HYPERTENSIVE CRISIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Vascular disorders HYPOTENSION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders FLUID OVERLOAD	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Renal and urinary disorders RENAL FAILURE CHRONIC	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).

Other adverse events

Other adverse events
Measure	Part 1 - Placebo n=1 participants at risk Participants received a single subcutaneous dose of placebo prior to dialysis on Day 1 via an IVRS.	Part 1 - ACE-011 0.1 mg/kg n=6 participants at risk Participants received a single subcutaneous dose of sotatercept (0.1 mg/kg) prior to dialysis on Day 1 via an IVRS	Part 2 - Placebo n=11 participants at risk Participants received a single subcutaneous dose of placebo	Part 2 - 0.3 mg/kg n=9 participants at risk Participants received a single subcutaneous dose of 0.3 mg/kg sotatercept every 28 days for up to 8 doses	Part 2 - 0.5 mg/kg n=8 participants at risk Participants received a single subcutaneous dose of 0.5 mg/kg sotatercept every 28 days for up to 8 doses	Part 2 - 0.7 mg/kg n=9 participants at risk Participants received a single subcutaneous dose of 0.7 mg/kg sotatercept every 28 days for up to 8 doses	Part 2 - 0.7/0.4 mg/kg n=6 participants at risk Participants received a subcutaneous dose of 0.7 mg/kg sotatercept loading followed by a subcutaneous dose of 0.4 mg/kg sotatercept every 14 days for up to 15 doses
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Cardiac disorders ANGINA UNSTABLE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Eye disorders RETINAL DETACHMENT	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Eye disorders VITREOUS HAEMORRHAGE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders CONSTIPATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	22.2% 2/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders DIARRHOEA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders NAUSEA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	44.4% 4/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders TOOTHACHE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders VOMITING	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders ASTHENIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders FATIGUE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	18.2% 2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	22.2% 2/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	33.3% 2/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders MEDICAL DEVICE COMPLICATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders OEDEMA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders OEDEMA PERIPHERAL	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders PAIN	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	22.2% 2/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations ACARODERMATITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations ARTERIOVENOUS FISTULA SITE INFECTION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations BACTERAEMIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations BRONCHITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations CELLULITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations CORNEAL INFECTION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations FOLLICULITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations GASTROENTERITIS VIRAL	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations OTITIS MEDIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations SINUSITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations STAPHYLOCOCCAL BACTERAEMIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations TOOTH INFECTION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations TRACHEOBRONCHITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations URINARY TRACT INFECTION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Infections and infestations VIRAL INFECTION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE COMPLICATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	33.3% 2/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA THROMBOSIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications ARTERIOVENOUS GRAFT SITE HAEMORRHAGE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications CONTUSION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications EXCORIATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications EYE PENETRATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications FALL	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications JOINT INJURY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications MENISCUS LESION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications SKELETAL INJURY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications SUTURE RELATED COMPLICATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations BLOOD PHOSPHORUS DECREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations BLOOD PHOSPHORUS INCREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	22.2% 2/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations C-REACTIVE PROTEIN INCREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations EOSINOPHIL COUNT INCREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations HEART RATE INCREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations HEPATIC ENZYME INCREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Investigations VITAMIN D DECREASED	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders HYPOGLYCAEMIA	100.0% 1/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders IRON DEFICIENCY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders TYPE 2 DIABETES MELLITUS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Musculoskeletal and connective tissue disorders ARTHRITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Nervous system disorders DIZZINESS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	22.2% 2/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Nervous system disorders HEADACHE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Nervous system disorders PRESYNCOPE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Nervous system disorders SCIATICA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Psychiatric disorders AGITATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Psychiatric disorders ANXIETY	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Psychiatric disorders INSOMNIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Renal and urinary disorders CHROMATURIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Respiratory, thoracic and mediastinal disorders RESPIRATORY TRACT CONGESTION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Skin and subcutaneous tissue disorders DRY GANGRENE	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Skin and subcutaneous tissue disorders PRURITUS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Vascular disorders HYPERTENSION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	9.1% 1/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	33.3% 3/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	44.4% 4/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Vascular disorders HYPOTENSION	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	18.2% 2/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Vascular disorders PERIPHERAL VASCULAR DISORDER	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	12.5% 1/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Vascular disorders STEAL SYNDROME	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	11.1% 1/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Blood and lymphatic system disorders ANAEMIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Eye disorders ORBITAL OEDEMA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders DRY MOUTH	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Gastrointestinal disorders DYSPEPSIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders CHILLS	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
General disorders PYREXIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE HAEMATOMA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).
Skin and subcutaneous tissue disorders RASH	0.00% 0/1 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	16.7% 1/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/11 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/8 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/9 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).	0.00% 0/6 • Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 66 months). SAEs and Other AEs were assessed from first dose up to 115 days post last dose (up to 340 days).

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

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